Trial Outcomes & Findings for A Myeloablative Conditioning Regimen and Total Body Irradiation Followed by the Transplantation for Patients With Hematological Malignancy (NCT NCT00597519)
NCT ID: NCT00597519
Last Updated: 2016-02-12
Results Overview
To obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
1 year
Results posted on
2016-02-12
Participant Flow
Participant milestones
| Measure |
Treatment
Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment
Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
A Myeloablative Conditioning Regimen and Total Body Irradiation Followed by the Transplantation for Patients With Hematological Malignancy
Baseline characteristics by cohort
| Measure |
Treatment
n=28 Participants
Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
|
|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 yearTo obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall response.
Outcome measures
| Measure |
Treatment
n=27 Participants
Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
|
|---|---|
|
Overall Response
Complete Remission
|
24 participants
|
|
Overall Response
Relapse
|
3 participants
|
Adverse Events
Treatment
Serious events: 8 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=28 participants at risk
Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
|
|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow, other
|
3.6%
1/28
|
|
General disorders
Death not associated with CTCAE term- Death NOS
|
14.3%
4/28
|
|
General disorders
Death not associated with CTCAE term- Sudden death
|
3.6%
1/28
|
|
General disorders
Death not associated with CTCAE term-Disease progression NOS
|
7.1%
2/28
|
|
General disorders
Pain - Abdomen NOS
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
3.6%
1/28
|
Other adverse events
| Measure |
Treatment
n=28 participants at risk
Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
7.1%
2/28
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
39.3%
11/28
|
|
Blood and lymphatic system disorders
Amylase
|
10.7%
3/28
|
|
Blood and lymphatic system disorders
AST, SGOT
|
32.1%
9/28
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
35.7%
10/28
|
|
Metabolism and nutrition disorders
Creatinine
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
57.1%
16/28
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
28/28
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
28/28
|
|
Metabolism and nutrition disorders
Lipase
|
7.1%
2/28
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
28/28
|
|
Metabolism and nutrition disorders
Magnesium, high (hypermagnesemia)
|
39.3%
11/28
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
28/28
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
25.0%
7/28
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
28/28
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
28.6%
8/28
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
53.6%
15/28
|
|
Blood and lymphatic system disorders
PTT
|
17.9%
5/28
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
32.1%
9/28
|
Additional Information
Dr. Juliet Barker
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3468
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place