Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (NCT NCT00576979)
NCT ID: NCT00576979
Last Updated: 2026-03-24
Results Overview
Toxicities will be recorded using two distinct grading systems: the modified Bearman scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0 scale.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
51 participants
Primary outcome timeframe
30 days post transplant
Results posted on
2026-03-24
Participant Flow
Participant milestones
| Measure |
Period 1: 1200cGy
150cGy BID x Days 1-4. Total dose 1200cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Period 2: 1350cGy
150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Period 3: 1500cGy (1200 cGy Limited Dose to Ribs, Sternum, Liver, Brain)
150cGy BID Day 1-5. Total dose 1500Gy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Period 4: 1500cGy (1200 cGy Limited Dose to Liver, Brain)
150cGy BID Day 1-5. Total dose 1500Gy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Period 5: 1600cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain)
160cGy BID Day 1-5. Total dose 1600Gy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Period 6: 1700cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain)
170cGy BID Day 1-5. Total dose 1700Gy. Patient age 18-55
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Period 7: 1800cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain)
180cGy BID Day 1-5. Total dose 1800cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Period 8: 1900cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain)
190cGy BID Day 1-5. Total dose 1900cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Period 9: 2000cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain)
200 cGy BID Day 1-5. Total dose 2000cGy
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
9
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
9
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Level 1: 1200cGy
n=3 Participants
150cGy BID x Days 1-4. Total dose 1200cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 2: 1350cGy
n=3 Participants
150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 3: 1500cGy Limited Dose to Ribs, Sternum, Liver, Brain 1200cGy
n=9 Participants
150cGy BID Day 1-5. Total dose 1500cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 4: 1500cGy Limited Dose to Liver, Brain 1200cGy
n=6 Participants
150cGy BID Day 1-5. Total dose 1500cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 5: 1600cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 Participants
160cGy BID Day 1-5. Total dose 1600cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 6: 1700cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 Participants
170cGy BID Day 1-5. Total dose 1700cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 7: 1800cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 Participants
180cGy BID Day 1-5. Total dose 1800cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 8: 1900cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 Participants
190cGy BID Day 1-5. Total dose 1900cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 9: 2000cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 Participants
200cGy BID Day 1-5. Total dose 2000cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3208 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
9 Participants
n=123 Participants
|
6 Participants
n=158 Participants
|
6 Participants
n=3208 Participants
|
6 Participants
n=1 Participants
|
6 Participants
n=2 Participants
|
6 Participants
n=2 Participants
|
5 Participants
n=2 Participants
|
50 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3208 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Age, Continuous
|
34.4 years
n=138 Participants
|
24.5 years
n=62 Participants
|
32.7 years
n=123 Participants
|
31.1 years
n=158 Participants
|
37.5 years
n=3208 Participants
|
52.5 years
n=1 Participants
|
36.5 years
n=2 Participants
|
38.4 years
n=2 Participants
|
39.4 years
n=2 Participants
|
34.4 years
n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
3 Participants
n=158 Participants
|
3 Participants
n=3208 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=2 Participants
|
5 Participants
n=2 Participants
|
4 Participants
n=2 Participants
|
31 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
3 Participants
n=158 Participants
|
3 Participants
n=3208 Participants
|
4 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
20 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
2 Participants
n=3208 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
10 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Black, not of Hispanic origin
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3208 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
3 Participants
n=158 Participants
|
2 Participants
n=3208 Participants
|
2 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=2 Participants
|
17 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Other, Unknown
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3208 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
3 Participants
n=158 Participants
|
2 Participants
n=3208 Participants
|
3 Participants
n=1 Participants
|
4 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
22 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=138 Participants
|
3 participants
n=62 Participants
|
9 participants
n=123 Participants
|
6 participants
n=158 Participants
|
6 participants
n=3208 Participants
|
6 participants
n=1 Participants
|
6 participants
n=2 Participants
|
6 participants
n=2 Participants
|
6 participants
n=2 Participants
|
51 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 30 days post transplantToxicities will be recorded using two distinct grading systems: the modified Bearman scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0 scale.
Outcome measures
| Measure |
All Levels: 1200 cGy to 2000cGy
n=51 Participants
Patient age 18-55
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
|---|---|
|
Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I)
|
2000 cGy
|
Adverse Events
Level 1: 1200cGy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Level 2: 1350cGy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Level 3: 1500cGy Limited Dose to Ribs, Sternum, Liver, Brain 1200cGy
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Level 4: 1500cGy Limited Dose to Liver, Brain 1200cGy
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Level 5: 1600cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Level 6: 1700cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Level 7: 1800cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Level 8: 1900cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Level 9: 2000cGy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Level 1: 1200cGy
n=3 participants at risk
150cGy BID x Days 1-4. Total dose 1200cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 2: 1350cGy
n=3 participants at risk
150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 3: 1500cGy Limited Dose to Ribs, Sternum, Liver, Brain 1200cGy
n=9 participants at risk
150cGy BID Day 1-5. Total dose 1500cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 4: 1500cGy Limited Dose to Liver, Brain 1200cGy
n=6 participants at risk
150cGy BID Day 1-5. Total dose 1500cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 5: 1600cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 participants at risk
160cGy BID Day 1-5. Total dose 1600cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 6: 1700cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 participants at risk
170cGy BID Day 1-5. Total dose 1700cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 7: 1800cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 participants at risk
180cGy BID Day 1-5. Total dose 1800cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 8: 1900cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 participants at risk
190cGy BID Day 1-5. Total dose 1900cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 9: 2000cGy
n=6 participants at risk
200cGy BID Day 1-5. Total dose 1900cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
10040047-Sepsis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10005364-Blood bilirubin increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Renal Toxicity
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10038695-Respiratory failure
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10065746-Bronchopulmonary hemorrhage
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Toxicity
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
Other adverse events
| Measure |
Level 1: 1200cGy
n=3 participants at risk
150cGy BID x Days 1-4. Total dose 1200cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 2: 1350cGy
n=3 participants at risk
150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 3: 1500cGy Limited Dose to Ribs, Sternum, Liver, Brain 1200cGy
n=9 participants at risk
150cGy BID Day 1-5. Total dose 1500cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 4: 1500cGy Limited Dose to Liver, Brain 1200cGy
n=6 participants at risk
150cGy BID Day 1-5. Total dose 1500cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 5: 1600cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 participants at risk
160cGy BID Day 1-5. Total dose 1600cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 6: 1700cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 participants at risk
170cGy BID Day 1-5. Total dose 1700cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 7: 1800cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 participants at risk
180cGy BID Day 1-5. Total dose 1800cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 8: 1900cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy
n=6 participants at risk
190cGy BID Day 1-5. Total dose 1900cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
Level 9: 2000cGy
n=6 participants at risk
200cGy BID Day 1-5. Total dose 1900cGy.
cyclophosphamide: Given IV
etoposide: Given IV
allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide
intensity-modulated radiation therapy: Undergo IMRT
tomotherapy: Undergo IMRT using helical tomotherapy
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
10002272-Anemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Edema:head and neck
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Edema:limb
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Edema:trunk/genital
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify, __) LYMPHADENOPATHY
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Platelets for BMT studies, if specified in the protocol.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets for BMT studies, if specified in the protocol.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs for BMT studies, if specified in the protocol.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
10040741-Sinus bradycardia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
10040752-Sinus tachycardia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __) TACHYCARDIA
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Cardiac Toxicity
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Hypertension
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Hypotension
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
6/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Pulmonary hypertension
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Eye disorders
10005886-Blurred vision
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __) CLOUDINESS LEFT CORNEA
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __) EYES STAY OPEN
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __) PALLOR OF CONJUNCTIVAE
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __) SCLERAL ICTERUS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10000081-Abdominal pain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10003445-Ascites
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10009887-Colitis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10010774-Constipation
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10012727-Diarrhea
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10013781-Dry mouth
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10013946-Dyspepsia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10013950-Dysphagia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10017853-Gastritis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10028130-Mucositis oral
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10028813-Nausea
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10031009-Oral pain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10047700-Vomiting
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10051746-Lower gastrointestinal hemorrhage
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
10065721-Anal mucositis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Anorexia
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
88.9%
8/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
55.6%
5/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Esophagitis
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) BELCHING
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) CHANGE IN BOWEL HABITS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) FREQUENT BOWEL MVMT
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) GI UPSET
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) LICHENOID CHANGES IN MOUTH
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) MOUTH SORE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) PERIANAL NUMBNESS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
GI Toxicity
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
6/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
55.6%
5/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Hemorrhoids
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10008531-Chills
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10014222-Edema face
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10016059-Facial pain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10016256-Fatigue
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10016558-Fever
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10017577-Gait disturbance
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10018065-General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10033371-Pain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10050068-Edema limbs
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10051792-Infusion related reaction
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
10062501-Non-cardiac chest pain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
88.9%
8/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
6/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Hypothermia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Insomnia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain - Other (Specify, __) GENERALIZED BODYACHE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain - Other (Specify, __) GENERALIZED PAIN
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain - Other (Specify, __) JAW PAIN
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain - Other (Specify, __) L/R SIDE BODY PAIN
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain - Other (Specify, __) MANDIBULAR
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain - Other (Specify, __) PICC LINE SITE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain - Other (Specify, __) PICC SITE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain - Other (Specify, __) TOOTH
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Pain CHEST NOS LEFT SIDE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Rigors/chills
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Syndromes - Other (Specify, __) ENGRAFTMENT SYN
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Syndromes - Other (Specify, __) ENGRAFTMENT SYNDROME
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Weight gain
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
General disorders
Weight loss
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Hepatobiliary disorders
Hepatic Toxicity
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
10021881-Infections and infestations - Other, specify
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
10040753-Sinusitis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
10046914-Vaginal infection
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
10058838-Enterocolitis infectious
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
10061229-Lung infection
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
Febrile neutropenia
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
Infection - Other (Specify, __) CMV INFECTION
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
Infection
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Infections and infestations
Stomatitis
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
88.9%
8/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Injury, poisoning and procedural complications
10006504-Bruising
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Injury, poisoning and procedural complications
10061103-Dermatitis radiation
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10000636-Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10001551-Alanine aminotransferase increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10001675-Alkaline phosphatase increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10003481-Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10005364-Blood bilirubin increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10011368-Creatinine increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10022402-INR increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10025256-Lymphocyte count decreased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10029366-Neutrophil count decreased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10035528-Platelet count decreased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10047896-Weight gain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10047900-Weight loss
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10049182-White blood cell decreased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10055599-Hemoglobin increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10056910-GGT increased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Investigations
10059895-Urine output decreased
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10000486-Acidosis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10001680-Alkalosis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10002646-Anorexia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10020587-Hypercalcemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10020639-Hyperglycemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10020647-Hyperkalemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10020670-Hypermagnesemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10020680-Hypernatremia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10020870-Hypertriglyceridemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10020943-Hypoalbuminemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10020949-Hypocalcemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10021005-Hypoglycemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10021018-Hypokalemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10021028-Hypomagnesemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10021038-Hyponatremia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
10021059-Hypophosphatemia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
6/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Amylase
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
88.9%
8/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
55.6%
5/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
88.9%
8/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __) CARBON DIOXIDE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __) HYPOVITAMINOSIS D
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __) HYPOGAMMAGLOBINEMIA
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Proteinuria
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __) HYPOGAMMAGLOBULINEMIA
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10013573-Dizziness
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
88.9%
8/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
9/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
88.9%
8/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Musculoskeletal and connective tissue disorders
10003988-Back pain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Musculoskeletal and connective tissue disorders
10006002-Bone pain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Musculoskeletal and connective tissue disorders
10028411-Myalgia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Musculoskeletal and connective tissue disorders
10033425-Pain in extremity
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029104-Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10013911-Dysgeusia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10019211-Headache
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10020765-Hypersomnia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10027175-Memory impairment
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10029205-Nervous system disorders - Other, specify
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10033987-Paresthesia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10034620-Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10041349-Somnolence
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
10044565-Tremor
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Apnea
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Confusion
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Neurology - Other (Specify, __) DISORIENTED
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Neurology - Other (Specify, __) LETHARGY
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Neurology - Other (Specify, __) NUMBNESS (B) FEET
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Neurology - Other (Specify, __) PERIPHERAL NEUROP.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Neurology - Other (Specify, __) RIGHT FACIAL NUMBNESS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Neuropathy: sensory
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
55.6%
5/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10001497-Agitation
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10002855-Anxiety
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10010300-Confusion
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10012260-Delusions
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10012378-Depression
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10019077-Hallucinations
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10022437-Insomnia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10037175-Psychiatric disorders - Other, specify
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
10038743-Restlessness
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
Irritability (children <3 years of age)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
Mood alteration
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
3/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
88.9%
8/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
Neurology - Other (Specify, __) ALTERED MENTAL STATUS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
10046539-Urinary frequency
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
10069339-Acute kidney injury
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Bladder Toxicity
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Cystitis
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Renal Toxicity
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __) DYSURIA
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __) MILD RENAL INSUFFICIENCY
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Renal and urinary disorders
Urine color change
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Reproductive system and breast disorders
10046901-Vaginal discharge
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Reproductive system and breast disorders
10046916-Vaginal inflammation
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Reproductive system and breast disorders
10061339-Perineal pain
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other (Specify, __) VAGINAL ITCHING
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10011224-Cough
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10013963-Dyspnea
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10020201-Hoarseness
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10028735-Nasal congestion
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10038695-Respiratory failure
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10041367-Sore throat
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
10065746-Bronchopulmonary hemorrhage
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Toxicity
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
22.2%
2/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) BRONCHITIS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) CHEST CONGESTION
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) NASAL DRIP
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) NASAL CONGESTION
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) NASAL DISCHARGE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) TACHPNEIC
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) TACHYPNEIC
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) WEEZING
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __) WHEEZING
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10001760-Alopecia
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10013786-Dry skin
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10015277-Erythroderma
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10033474-Pain of skin
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10037087-Pruritus
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10037847-Rash acneiform
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10037868-Rash maculo-papular
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10040865-Skin hyperpigmentation
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10040868-Skin hypopigmentation
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
10054524-Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) ABRASION-LOWER THIGHS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) ACTINIC KERATOSIS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) BUMPS - BUTTOCK AREA
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) CONTUSION - HEAD
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) PALE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) DARKNESS OF SKIN
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) FOLLICULITIS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) ONYCHOLYSIS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) PALLOR OF FACE
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) PEELING OF FINGERS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) PEELING OF SKIN
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) SCALP LESIONS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) SEBORRHEIC KERATOSIS
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) SKIN ERYTHEMA
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) SKIN PEELING
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) SKIN SENSITIVITY
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) SKIN TEAR RLQ
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
55.6%
5/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
6/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
77.8%
7/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
83.3%
5/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
3/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
10020772-Hypertension
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
100.0%
6/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
10021097-Hypotension
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Hemorrhage, GI
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Hemorrhage, GU
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
2/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
6/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
66.7%
4/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory
|
33.3%
1/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
44.4%
4/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
50.0%
3/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __) RETINAL HEMORRHAGE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __) RIGHT EYE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __) RIGHT RETINAL HEMORRHAGE
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
33.3%
2/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
PTT (Partial Thromboplastin Time)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
16.7%
1/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
|
Vascular disorders
Thrombotic microangiopathy
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/3 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
11.1%
1/9 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
0.00%
0/6 • Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
|
Additional Information
Anthony Stein, MD, corresponding author
Department of Hematology and Hematopoietic Cell Transplantation, City of Hope
Phone: 626-256-4673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place