Trial Outcomes & Findings for Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease (NCT NCT00719849)
NCT ID: NCT00719849
Last Updated: 2017-06-14
Results Overview
Kaplan-Meier estimate of the probability of survival at 1 year
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
1 year post transplant
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease
Baseline characteristics by cohort
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=9 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
n=99 Participants
|
55.1 years
n=107 Participants
|
53.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Disease Diagnosis
AML (Acute Myeloid Leukemia)
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Disease Diagnosis
CML (Chronic Myeloid Leukemia)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Disease Diagnosis
NHL (Non-Hodgkin's Lymphoma)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Disease Diagnosis
MDS (Myelodysplastic Syndromes)
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 year post transplantKaplan-Meier estimate of the probability of survival at 1 year
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Probability of Survival at 1 Year
|
0.25 survival probability
Interval 0.046 to 1.0
|
0.50 survival probability
Interval 0.25 to 1.0
|
SECONDARY outcome
Timeframe: 2 years post transplantKaplan-Meier estimate of the probability of survival at 2 years
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Probability of Survival at 2 Years
|
0.25 survival probability
Interval 0.046 to 1.0
|
0.38 survival probability
Interval 0.15 to 0.92
|
SECONDARY outcome
Timeframe: 6 months post transplantNumber of Participants with Non-relapse Mortality at 6 Months
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Non-relapse Mortality at 6 Months
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplantCount of participants who experienced dominance of one cord blood unit (defined by \>or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Chimerism
Day 7
|
0 Participants
|
0 Participants
|
|
Chimerism
Day 14
|
0 Participants
|
0 Participants
|
|
Chimerism
Day 21
|
1 Participants
|
1 Participants
|
|
Chimerism
Day 28
|
1 Participants
|
5 Participants
|
|
Chimerism
Day 56
|
1 Participants
|
5 Participants
|
|
Chimerism
Day 80
|
1 Participants
|
6 Participants
|
|
Chimerism
6 months
|
2 Participants
|
7 Participants
|
|
Chimerism
1 year
|
2 Participants
|
7 Participants
|
|
Chimerism
2 years
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 42 post transplantNumber of participants with neutrophil engraftment at day 42
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Neutrophil Engraftment at Day 42
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantNumber of participants with platelet engraftment at 6 months
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Platelet Engraftment at 6 Months
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 100 post transplantNumber of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 100 post transplantNumber of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 year post transplantNumber of participants with chronic graft-versus-host-disease (GVHD) at 1 year. Clinical Limited cGVHD 1. Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD. 2. Mild liver test abnormalities (alkaline phosphatase \<2 x upper limit of normal, AST or ALT \<3 x upper limit of normal and total bilirubin \<1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD. 3. Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving \<20% of body surface area (BSA), dyspigmentation involving \<20% BSA, or erythema involving \<50% BSA, positive skin biopsy, and no other manifestations of cGVHD. 4. Ocular sicca (Schirmer's test \<5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD. 5. Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD.
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantNumber of participants with clinically significant infections at 6 months
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Clinically Significant Infections at 6 Months
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 year post transplantNumber of participants with clinically significant infections at 1 year
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Clinically Significant Infections at 1 Year
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 years post transplantNumber of participants with clinically significant infections at 2 years
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Clinically Significant Infections at 2 Years
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 year post transplantKaplan-Meier estimate of the probability of progression-free survival at 1 year
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Probability of Progression-free Survival at 1 Year
|
0.25 progression free survival probability
Interval 0.046 to 1.0
|
0.38 progression free survival probability
Interval 0.15 to 0.92
|
SECONDARY outcome
Timeframe: 2 years post transplantKaplan-Meier estimate of the probability of progression-free survival at 2 years
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=9 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Probability of Progression-free Survival at 2 Years
|
0.25 progression free survival probability
Interval 0.046 to 1.0
|
0.25 progression free survival probability
Interval 0.075 to 0.83
|
SECONDARY outcome
Timeframe: 1 year post transplantNumber of participants with relapse at 1 year. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Relapse at 1 Year
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 years post transplantNumber of participants with relapse at 2 years. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Outcome measures
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 Participants
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=8 Participants
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Incidence of Relapse at 2 Years
|
1 Participants
|
5 Participants
|
Adverse Events
Cyclophosphamide/Fludarabine/TBI
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Cyclophosphamide/Fludarabine/TBI/ATG
Serious events: 8 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 participants at risk
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=9 participants at risk
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Investigations
Death
|
75.0%
3/4 • Number of events 3
|
88.9%
8/9 • Number of events 8
|
|
Blood and lymphatic system disorders
Relapse of underlying disease
|
25.0%
1/4 • Number of events 1
|
55.6%
5/9 • Number of events 5
|
|
Cardiac disorders
Congestive heart failure
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
General disorders
MSOF leading to death
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Fever of unknown etiology
|
25.0%
1/4 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Creatinine Phosphokinase
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
|
Infections and infestations
Infection with grade 3 ANC - blood
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Infection with grade 3 ANC - lungs
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Infection with normal ANC - blood
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Opportunistic infection associated with lymphopenia
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction, GI - biliary tree
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1
|
22.2%
2/9 • Number of events 4
|
|
Cardiac disorders
Hypertension
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Failure to engraft by day 42
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Encephalitis HHV6
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Secondary graft failure
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Acute renal failure
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary VOD
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Cyclophosphamide/Fludarabine/TBI
n=4 participants at risk
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
Cyclophosphamide/Fludarabine/TBI/ATG
n=9 participants at risk
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
|
|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
25.0%
1/4 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium, serum-high
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Potassium, serum-low
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, serum-low
|
50.0%
2/4 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
1/4 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
25.0%
1/4 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Vascular disorders
Thrombus
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, serum-low
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, serum-high
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Neutrophils
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
25.0%
1/4 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Infection with grade 2 ANC - skin
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Infection with normal ANC - blood
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Infection with grade 4 ANC - blood
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Infection with grade 4 ANC - oral
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
AST
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
Additional Information
Dr. Colleen Delaney
Fred Hutchinson Cancer Research Center
Phone: 2066671385
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place