Trial Outcomes & Findings for Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders (NCT NCT00397813)
NCT ID: NCT00397813
Last Updated: 2020-01-31
Results Overview
HCT failure will be defined as graft rejection (defined as \< 5% donor T-cell chimerism) or disease progression within 200 days of transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
200 days
Results posted on
2020-01-31
Participant Flow
Participant milestones
| Measure |
Arm A - Dose Level 1
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
0
|
0
|
12
|
5
|
24
|
|
Overall Study
COMPLETED
|
36
|
0
|
0
|
12
|
5
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders
Baseline characteristics by cohort
| Measure |
Arm A - Dose Level 1
n=36 Participants
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
n=12 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
n=5 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
n=24 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Age, Continuous
|
64.5 years
n=93 Participants
|
—
|
—
|
66.5 years
n=483 Participants
|
68 years
n=36 Participants
|
68.5 years
n=10 Participants
|
67 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
—
|
—
|
7 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
—
|
—
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=93 Participants
|
—
|
—
|
12 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
23 Participants
n=10 Participants
|
74 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=93 Participants
|
—
|
—
|
12 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
70 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
—
|
—
|
12 participants
n=483 Participants
|
5 participants
n=36 Participants
|
24 participants
n=10 Participants
|
77 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 200 daysPopulation: No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
HCT failure will be defined as graft rejection (defined as \< 5% donor T-cell chimerism) or disease progression within 200 days of transplant.
Outcome measures
| Measure |
Arm A - Dose Level 1
n=36 Participants
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
n=12 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
n=5 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
n=24 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
|---|---|---|---|---|---|---|
|
Number of Patients With HCT Failure.
|
4 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
Number of patients who experienced bacterial, fungal, or viral infections.
Outcome measures
| Measure |
Arm A - Dose Level 1
n=36 Participants
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
n=12 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
n=5 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
n=24 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
|---|---|---|---|---|---|---|
|
Number of Patients Who Had Infections
|
24 Participants
|
0 Participants
|
0 Participants
|
12 Participants
|
4 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%.
Outcome measures
| Measure |
Arm A - Dose Level 1
n=36 Participants
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
n=12 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
n=5 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
n=24 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
|---|---|---|---|---|---|---|
|
Number of Patients Who Engrafted
|
35 Participants
|
0 Participants
|
0 Participants
|
12 Participants
|
4 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.
Outcome measures
| Measure |
Arm A - Dose Level 1
n=36 Participants
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
n=12 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
n=5 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
n=24 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Progression-free Survival
|
24 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.
Outcome measures
| Measure |
Arm A - Dose Level 1
n=36 Participants
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
n=12 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
n=5 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
n=24 Participants
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Relapse/Progression
|
6 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
Adverse Events
Arm A - Dose Level 1
Serious events: 3 serious events
Other events: 16 other events
Deaths: 10 deaths
Arm A - Dose Level 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm A - Dose Level 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B - Dose Level 1
Serious events: 7 serious events
Other events: 9 other events
Deaths: 10 deaths
Arm B - Dose Level 2
Serious events: 2 serious events
Other events: 2 other events
Deaths: 3 deaths
Arm B - Dose Level 3
Serious events: 4 serious events
Other events: 13 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Arm A - Dose Level 1
n=36 participants at risk
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
n=12 participants at risk
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
n=5 participants at risk
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
n=24 participants at risk
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Investigations
Blood bilirubin increased
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
20.0%
1/5 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Immune system disorders
GVHD
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Infections and infestations
Lung infection
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
20.0%
1/5 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
General disorders
Multi-organ failure
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
16.7%
2/12 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify (altered mental status)
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Nervous system disorders
Seizure
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Psychiatric disorders
Suicide attempt
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
Other adverse events
| Measure |
Arm A - Dose Level 1
n=36 participants at risk
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 2
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm A - Dose Level 3
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 1
n=12 participants at risk
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 2
n=5 participants at risk
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
Arm B - Dose Level 3
n=24 participants at risk
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI
NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.
IMMUNOSUPPRESSION:
Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.
Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
2/24 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
2/24 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Investigations
Blood antidiuretic hormone abnormal
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Investigations
Blood bilirubin increased
|
25.0%
9/36 • Number of events 11 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
25.0%
3/12 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
40.0%
2/5 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
25.0%
6/24 • Number of events 6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
2/36 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
33.3%
4/12 • Number of events 4 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
20.8%
5/24 • Number of events 5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
General disorders
Flu like symptoms
|
2.8%
1/36 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
20.0%
1/5 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
16.7%
2/12 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
2/24 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
4/36 • Number of events 6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
25.0%
3/12 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
40.0%
2/5 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
20.8%
5/24 • Number of events 5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Cardiac disorders
Pericardial effusion
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Infections and infestations
Sepsis
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
20.0%
1/5 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/24 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Nervous system disorders
Syncope
|
0.00%
0/36 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
4.2%
1/24 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
|
Vascular disorders
Thromboembolic event
|
2.8%
1/36 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
8.3%
1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
0.00%
0/5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
12.5%
3/24 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
|
Additional Information
Dr. Brenda M. Sandmaier
Fred Hutchinson Cancer Research Center
Phone: (206) 667-4961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place