Trial Outcomes & Findings for Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant (NCT NCT00305682)
NCT ID: NCT00305682
Last Updated: 2020-11-19
Results Overview
Overall Survival - Number of patients alive at 1 year post transplant
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
295 participants
Primary outcome timeframe
1 Year
Results posted on
2020-11-19
Participant Flow
7 patients were excluded from receiving the treatment as they were not eligible. 4 patients were removed from the study because the participating site withdrew the participation from the study
Participant milestones
| Measure |
Arm 1-Previous Autologous Transplant
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
71
|
7
|
34
|
39
|
35
|
|
Overall Study
COMPLETED
|
98
|
71
|
7
|
34
|
39
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant
Baseline characteristics by cohort
| Measure |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
218 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
55 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
116 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
168 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
248 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
71 participants
n=7 Participants
|
7 participants
n=5 Participants
|
34 participants
n=4 Participants
|
39 participants
n=21 Participants
|
35 participants
n=8 Participants
|
284 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 1 YearOverall Survival - Number of patients alive at 1 year post transplant
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Were Alive at 1 Year Post Transplant
|
59 Participants
|
40 Participants
|
1 Participants
|
26 Participants
|
26 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 2 YearsOverall Survival - Number of patients alive at 2 years post transplant
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Were Alive at 2 Years Post Transplant
|
50 Participants
|
31 Participants
|
1 Participants
|
20 Participants
|
21 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Month 6Incidence of Non-relapse mortality - Number of Patients Dead at 6 Months after study completion
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Were Dead at 6 Months After Study Completion
|
10 Participants
|
20 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: A total of 43 participants were not evaluable
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=86 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=61 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=6 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=25 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=35 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=28 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Percentage of Donor Chimerism at 21 Days
|
77 percentage of donor cells
Standard Deviation 25
|
73 percentage of donor cells
Standard Deviation 32
|
57 percentage of donor cells
Standard Deviation 29
|
77 percentage of donor cells
Standard Deviation 21
|
69 percentage of donor cells
Standard Deviation 32
|
68 percentage of donor cells
Standard Deviation 33
|
SECONDARY outcome
Timeframe: 100 daysPopulation: A total of 85 participants were not evaluable.
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=64 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=50 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=2 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=30 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=27 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=26 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Percentage of Donor Chimerism at 100 Days
|
94 percentage of donor cells
Standard Deviation 18
|
94 percentage of donor cells
Standard Deviation 21
|
100 percentage of donor cells
Standard Deviation 0
|
93 percentage of donor cells
Standard Deviation 23
|
85 percentage of donor cells
Standard Deviation 31
|
86 percentage of donor cells
Standard Deviation 32
|
SECONDARY outcome
Timeframe: 180 DaysPopulation: A total of 134 participants were not evaluable
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=49 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=32 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=2 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=22 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=22 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=23 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Percentage of Donor Chimerism at 180 Days
|
96 percentage of donor cells
Standard Deviation 18
|
98 percentage of donor cells
Standard Deviation 6
|
88 percentage of donor cells
Standard Deviation 17
|
94 percentage of donor cells
Standard Deviation 16
|
91 percentage of donor cells
Standard Deviation 26
|
98 percentage of donor cells
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 365 daysPopulation: A total of 160 participants were not evaluable
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=42 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=27 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=19 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=16 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=20 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Percentage of Donor Chimerism at 365 Days
|
99 percentage of donor cells
Standard Deviation 2
|
98 percentage of donor cells
Standard Deviation 12
|
—
|
99 percentage of donor cells
Standard Deviation 6
|
87 percentage of donor cells
Standard Deviation 34
|
100 percentage of donor cells
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 42Population: 7 participants were not evaluable
Time to 1st 3 consecutive days with absolute neutrophil count (ANC) \> 5 x 10\^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=97 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=67 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=38 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=34 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Neutrophil Engraftment
|
93 Participants
|
65 Participants
|
6 Participants
|
32 Participants
|
32 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: 13 participants were not evaluable
Time to platelets \> 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment \>50,000 by day 100.
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=96 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=63 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=37 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=34 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Platelet Engraftment
|
75 Participants
|
47 Participants
|
3 Participants
|
28 Participants
|
34 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Day 100Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Acute Graft-versus-host Disease (GVHD)
|
45 Participants
|
24 Participants
|
1 Participants
|
12 Participants
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 1 YearDetermine the incidence of chronic GVHD at 1 year after transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Chronic Graft-Versus-Host Disease
|
18 Participants
|
20 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 YearIncidence of Progression-free survival - Number of patients who were alive and did not have disease progression. Patients with leukemia and lymphoma involving the bone marrow (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 |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Progression-free Survival
|
43 Participants
|
32 Participants
|
1 Participants
|
21 Participants
|
16 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 2 YearsIncidence of Progression-free survival - Number of patients who were alive and did not have disease progression
Outcome measures
| Measure |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Progression-free Survival at 2 Years
|
36 Participants
|
25 Participants
|
1 Participants
|
17 Participants
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Year 1Patients 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 |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Relapse (Incidence of Relapse)
|
43 Participants
|
14 Participants
|
4 Participants
|
7 Participants
|
20 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPatients 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 |
Arm 1-Previous Autologous Transplant
n=98 Participants
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 Participants
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 Participants
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 Participants
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 Participants
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 Participants
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years
|
49 Participants
|
19 Participants
|
4 Participants
|
11 Participants
|
20 Participants
|
4 Participants
|
Adverse Events
Arm 1-Previous Autologous Transplant
Serious events: 53 serious events
Other events: 76 other events
Deaths: 48 deaths
Arm 2 - No Prior Autologous Transplant
Serious events: 48 serious events
Other events: 54 other events
Deaths: 40 deaths
Arm 3 - Refractory Leukemia/Lymphoma
Serious events: 3 serious events
Other events: 5 other events
Deaths: 6 deaths
Arm 4: MT2006-01 Coenrolling Patients
Serious events: 11 serious events
Other events: 20 other events
Deaths: 14 deaths
Arm 5 - Previous Autologous Transplant
Serious events: 2 serious events
Other events: 33 other events
Deaths: 18 deaths
Arm 6 - No Prior Autologous Transplant
Serious events: 4 serious events
Other events: 35 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Arm 1-Previous Autologous Transplant
n=98 participants at risk
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 participants at risk
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 participants at risk
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 participants at risk
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 participants at risk
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 participants at risk
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary Graft Failure
|
0.00%
0/98 • 2 years
|
1.4%
1/71 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow,other - relapse disease
|
0.00%
0/98 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
5.9%
2/34 • Number of events 2 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Bone marrow cellularity - aplasia
|
0.00%
0/98 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Immune system disorders
Graft versus host disease
|
4.1%
4/98 • Number of events 4 • 2 years
|
7.0%
5/71 • Number of events 5 • 2 years
|
0.00%
0/7 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Cardiac disorders
Cardiovascular, other disorder - substernal chest discomfort
|
1.0%
1/98 • Number of events 1 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin disorder
|
0.00%
0/98 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Blood and lymphatic system disorders
CNS hemorrhage/bleeding
|
1.0%
1/98 • Number of events 1 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
0.00%
0/35 • 2 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/98 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Infections and infestations
Infection without neutropenia
|
1.0%
1/98 • Number of events 1 • 2 years
|
1.4%
1/71 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
19.4%
19/98 • Number of events 19 • 2 years
|
33.8%
24/71 • Number of events 24 • 2 years
|
28.6%
2/7 • Number of events 2 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
|
8.2%
8/98 • Number of events 8 • 2 years
|
2.8%
2/71 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse
|
19.4%
19/98 • Number of events 19 • 2 years
|
15.5%
11/71 • Number of events 11 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
8.8%
3/34 • Number of events 3 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Nervous system disorders
Leukoencephalopathy associated with radiological findings
|
0.00%
0/98 • 2 years
|
1.4%
1/71 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
0.00%
0/98 • 2 years
|
1.4%
1/71 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia
|
0.00%
0/98 • 2 years
|
2.8%
2/71 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Nervous system disorders
Guillamme Barre syndrome
|
0.00%
0/98 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
Other adverse events
| Measure |
Arm 1-Previous Autologous Transplant
n=98 participants at risk
hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 2 - No Prior Autologous Transplant
n=71 participants at risk
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 3 - Refractory Leukemia/Lymphoma
n=7 participants at risk
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 4: MT2006-01 Coenrolling Patients
n=34 participants at risk
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 5 - Previous Autologous Transplant
n=39 participants at risk
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
Arm 6 - No Prior Autologous Transplant
n=35 participants at risk
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
3/98 • Number of events 3 • 2 years
|
4.2%
3/71 • Number of events 3 • 2 years
|
0.00%
0/7 • 2 years
|
5.9%
2/34 • Number of events 3 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
11.4%
4/35 • Number of events 5 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
1/98 • Number of events 1 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
5.9%
2/34 • Number of events 2 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
8.2%
8/98 • Number of events 16 • 2 years
|
7.0%
5/71 • Number of events 5 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Bleeding
|
8.2%
8/98 • Number of events 9 • 2 years
|
8.5%
6/71 • Number of events 6 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
10.3%
4/39 • Number of events 7 • 2 years
|
5.7%
2/35 • Number of events 3 • 2 years
|
|
Infections and infestations
Cytomegaloviral infection
|
13.3%
13/98 • Number of events 14 • 2 years
|
7.0%
5/71 • Number of events 6 • 2 years
|
14.3%
1/7 • Number of events 2 • 2 years
|
5.9%
2/34 • Number of events 2 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
17.1%
6/35 • Number of events 6 • 2 years
|
|
Renal and urinary disorders
Dialysis
|
4.1%
4/98 • Number of events 4 • 2 years
|
11.3%
8/71 • Number of events 9 • 2 years
|
0.00%
0/7 • 2 years
|
5.9%
2/34 • Number of events 2 • 2 years
|
0.00%
0/39 • 2 years
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Deep vein thrombosis (DVT)
|
4.1%
4/98 • Number of events 4 • 2 years
|
2.8%
2/71 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
7.7%
3/39 • Number of events 3 • 2 years
|
0.00%
0/35 • 2 years
|
|
Nervous system disorders
Encephalopathy
|
1.0%
1/98 • Number of events 1 • 2 years
|
1.4%
1/71 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
General disorders
Engraftment syndrome
|
1.0%
1/98 • Number of events 1 • 2 years
|
2.8%
2/71 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
5.9%
2/34 • Number of events 2 • 2 years
|
17.9%
7/39 • Number of events 7 • 2 years
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
GI disorder
|
5.1%
5/98 • Number of events 6 • 2 years
|
4.2%
3/71 • Number of events 4 • 2 years
|
0.00%
0/7 • 2 years
|
5.9%
2/34 • Number of events 3 • 2 years
|
7.7%
3/39 • Number of events 3 • 2 years
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Cardiac disorders
Heart disorder
|
4.1%
4/98 • Number of events 7 • 2 years
|
8.5%
6/71 • Number of events 10 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
8.8%
3/34 • Number of events 4 • 2 years
|
15.4%
6/39 • Number of events 10 • 2 years
|
20.0%
7/35 • Number of events 10 • 2 years
|
|
Cardiac disorders
Heart failure
|
1.0%
1/98 • Number of events 1 • 2 years
|
0.00%
0/71 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
3.1%
3/98 • Number of events 3 • 2 years
|
2.8%
2/71 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
5.1%
2/39 • Number of events 2 • 2 years
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Vascular disorders
Hypertension
|
4.1%
4/98 • Number of events 4 • 2 years
|
2.8%
2/71 • Number of events 2 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
5.9%
2/34 • Number of events 2 • 2 years
|
15.4%
6/39 • Number of events 6 • 2 years
|
14.3%
5/35 • Number of events 5 • 2 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
4.1%
4/98 • Number of events 4 • 2 years
|
4.2%
3/71 • Number of events 3 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
8.8%
3/34 • Number of events 3 • 2 years
|
23.1%
9/39 • Number of events 9 • 2 years
|
28.6%
10/35 • Number of events 10 • 2 years
|
|
Infections and infestations
Infection
|
32.7%
32/98 • Number of events 114 • 2 years
|
25.4%
18/71 • Number of events 51 • 2 years
|
57.1%
4/7 • Number of events 23 • 2 years
|
32.4%
11/34 • Number of events 27 • 2 years
|
84.6%
33/39 • Number of events 101 • 2 years
|
94.3%
33/35 • Number of events 122 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Intubation
|
12.2%
12/98 • Number of events 20 • 2 years
|
21.1%
15/71 • Number of events 20 • 2 years
|
28.6%
2/7 • Number of events 5 • 2 years
|
14.7%
5/34 • Number of events 7 • 2 years
|
5.1%
2/39 • Number of events 2 • 2 years
|
17.1%
6/35 • Number of events 10 • 2 years
|
|
Infections and infestations
mastoiditis
|
0.00%
0/98 • 2 years
|
1.4%
1/71 • Number of events 2 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
0.00%
0/39 • 2 years
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
2.0%
2/98 • Number of events 2 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Nervous system disorders
Neuropathy
|
6.1%
6/98 • Number of events 6 • 2 years
|
2.8%
2/71 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
8.8%
3/34 • Number of events 4 • 2 years
|
0.00%
0/39 • 2 years
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Nervous system disorders
neurotoxicity
|
2.0%
2/98 • Number of events 3 • 2 years
|
15.5%
11/71 • Number of events 14 • 2 years
|
28.6%
2/7 • Number of events 4 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
5.1%
2/39 • Number of events 3 • 2 years
|
8.6%
3/35 • Number of events 4 • 2 years
|
|
Cardiac disorders
pericardial effusion
|
10.2%
10/98 • Number of events 11 • 2 years
|
19.7%
14/71 • Number of events 17 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
11.8%
4/34 • Number of events 4 • 2 years
|
12.8%
5/39 • Number of events 6 • 2 years
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
39.8%
39/98 • Number of events 86 • 2 years
|
52.1%
37/71 • Number of events 81 • 2 years
|
57.1%
4/7 • Number of events 15 • 2 years
|
38.2%
13/34 • Number of events 28 • 2 years
|
46.2%
18/39 • Number of events 37 • 2 years
|
57.1%
20/35 • Number of events 60 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hemorrhage
|
3.1%
3/98 • Number of events 3 • 2 years
|
14.1%
10/71 • Number of events 11 • 2 years
|
42.9%
3/7 • Number of events 3 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
11.4%
4/35 • Number of events 5 • 2 years
|
|
Nervous system disorders
Seizure
|
1.0%
1/98 • Number of events 5 • 2 years
|
0.00%
0/71 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
0.00%
0/34 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin rashes due to drug toxicity
|
0.00%
0/98 • 2 years
|
0.00%
0/71 • 2 years
|
0.00%
0/7 • 2 years
|
2.9%
1/34 • Number of events 4 • 2 years
|
7.7%
3/39 • Number of events 3 • 2 years
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Cardiac disorders
Supraventricular tachycardia (SVT)
|
1.0%
1/98 • Number of events 1 • 2 years
|
0.00%
0/71 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
0.00%
0/34 • 2 years
|
0.00%
0/39 • 2 years
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/98 • 2 years
|
0.00%
0/71 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
2.6%
1/39 • Number of events 1 • 2 years
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.0%
1/98 • Number of events 1 • 2 years
|
1.4%
1/71 • Number of events 1 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
0.00%
0/39 • 2 years
|
0.00%
0/35 • 2 years
|
Additional Information
Dr.Claudio G. Brunstein MD, PhD
Masonic Cancer Center, University of Minnesota
Phone: 612-625-3918
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place