Trial Outcomes & Findings for Clofarabine and Low-Dose Total-Body Irradiation in Treating Patients With Acute Myeloid Leukemia Undergoing Donor Peripheral Blood Stem Cell Transplant (NCT NCT01252667)
NCT ID: NCT01252667
Last Updated: 2020-04-16
Results Overview
The primary objective of part 1 is to determined the highest dose of clofarabine that can be tolerated safely in conjunction with nonmyeloablative transplant. If three patients successfully transplant without DLT, dose escalation occurs. If one of those three patients experiences DLT an additional three patients will be treated using the same dose. If a second DLT is observed in the first 3-6 patients, or if three patients are successfully transplanted without DLT at the highest dose the study will proceed to Part 2 using the maximum tolerated dose. A Clofarabine related dose-limiting toxicity is defined as a grade 4 toxicity involving the lungs, heart, liver (not resolving in 48 hours), kidneys (not resolving in 48 hours), gastrointestinal tract, and/or central nervous system.
COMPLETED
PHASE2
44 participants
14 days post-transplant
2020-04-16
Participant Flow
Participant milestones
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
0
|
0
|
35
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
0
|
0
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Overall Study
Transplant aborted post-conditioning
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Clofarabine and Low-Dose Total-Body Irradiation in Treating Patients With Acute Myeloid Leukemia Undergoing Donor Peripheral Blood Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
n=35 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
—
|
8 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
27 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Age, Continuous
|
73.4 years
n=5 Participants
|
64.1 years
n=7 Participants
|
67.7 years
n=5 Participants
|
—
|
—
|
69.5 years
n=8 Participants
|
69.1 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
—
|
13 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
22 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
—
|
—
|
31 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
—
|
—
|
32 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
—
|
—
|
35 participants
n=8 Participants
|
44 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 14 days post-transplantPopulation: Analysis only applies to subjects accrued in Part 1 of the study.
The primary objective of part 1 is to determined the highest dose of clofarabine that can be tolerated safely in conjunction with nonmyeloablative transplant. If three patients successfully transplant without DLT, dose escalation occurs. If one of those three patients experiences DLT an additional three patients will be treated using the same dose. If a second DLT is observed in the first 3-6 patients, or if three patients are successfully transplanted without DLT at the highest dose the study will proceed to Part 2 using the maximum tolerated dose. A Clofarabine related dose-limiting toxicity is defined as a grade 4 toxicity involving the lungs, heart, liver (not resolving in 48 hours), kidneys (not resolving in 48 hours), gastrointestinal tract, and/or central nervous system.
Outcome measures
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 months post-transplantPopulation: Analysis only applies to subjects accrued in Part 2 of the study. Two subjects in Low Risk status and not evaluable toward this outcome. One subject aborted transplant during conditioning and subsequently expired. This subject was counted towards accrual but not evaluated with respect to outcome measures.
Number of high risk patients with relapsed disease after receiving the maximum dose of clofarabine. Relapse is defined as the presence of \>5% aberrant blasts by morphology on a marrow aspirate or the presence of circulating blasts in the peripheral blood.
Outcome measures
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
n=32 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Relapsed Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 Year post-transplantPopulation: No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
Number of patients surviving without progressive disease post-transplant. Progression is defined as the presence of \>5% aberrant blasts by morphology on a marrow aspirate or the presence of circulating blasts in the peripheral blood.
Outcome measures
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
n=35 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Number of Participants Surviving Progression-free.
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 1 Year post-transplantPopulation: No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
Number of patients surviving overall post-transplant.
Outcome measures
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
n=35 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Number of Participants Surviving Overall
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 100 days post-transplantPopulation: No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
Number of patients who expired without disease progression/relapse.
Outcome measures
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
n=35 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Number of Non-Relapse Mortalities (NRM)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 Year post-transplant.Population: No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1. One subject on Part 2 Dose 3 aborted transplant during conditioning and subsequently expired. This subject was counted towards accrual but not evaluated with respect to outcome measures.
Number of patients who graft rejected post-transplant. Graft rejection is defined as \<5% donor peripheral blood T cells (CD3+).
Outcome measures
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
n=34 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Graft Rejected.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 Year post-transplantPopulation: The studies have not been carried out on the specimens to evaluate this outcome measure.
Potential prognostic markers will be assessed by polymerase chain reaction (PCR) to determine their prognostic value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 Year post-transplantPopulation: No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1. One subject on Part 2 Dose 3 aborted transplant during conditioning and subsequently expired. This subject was counted towards accrual but not evaluated with respect to outcome measures.
Number of patients with MRD post-transplant, detected in the bone marrow as cytogenetic abnormalities or \<5% monoclonal blasts by flow cytometry.
Outcome measures
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
n=35 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Number of Participants With Minimal Residual/Recurring Disease (MRD) Post-transplant
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Blood was drawn on day -6 before the first clofarabine dosing, at the end of the infusion, and at 3, 4, 5, 6 and 24 hours after the start of infusion. Only pre-dose samples were drawn on days -5, -4, and -3.Population: Pharmacokinetic analyses were performed on only a subset of patients.
Pharmacokinetic measurement of the volume of plasma from which clofarabine is completely removed per unit time. Clearance normalized to actual body weight. Pharmacokinetic analyses were performed on only a subset of patients and no aggregate calculations were made using the data.
Outcome measures
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=2 Participants
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 Participants
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Clofarabine
ID 1
|
—
|
0.53 L/h/kg
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Clofarabine
ID 2
|
—
|
0.37 L/h/kg
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Clofarabine
ID 4
|
—
|
—
|
0.29 L/h/kg
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Clofarabine
ID 5
|
—
|
—
|
0.40 L/h/kg
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Clofarabine
ID 6
|
—
|
—
|
0.50 L/h/kg
|
—
|
—
|
—
|
Adverse Events
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 - Dose 1 (30 mg/m^2 Clofarabine)
n=3 participants at risk
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 2 (40 mg/m^2 Clofarabine)
n=3 participants at risk
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 1 - Dose 3 (50 mg/m^2 Clofarabine)
n=3 participants at risk
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 1 (30 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 30 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 2 (40 mg/m^2 Clofarabine)
CONDITIONING REGIMEN: Patients receive 40 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
n=35 participants at risk
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/35 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
8.6%
3/35 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/35 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
5.7%
2/35 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
5.7%
2/35 • Number of events 5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
8.6%
3/35 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Cardiac disorders
Constrictive pericarditis
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
11.4%
4/35 • Number of events 4 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
8.6%
3/35 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
8.6%
3/35 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
General disorders
Fever
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/35 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
5.7%
2/35 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
5.7%
2/35 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Investigations
Weight gain
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
33.3%
1/3 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/35 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
0.00%
0/3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
|
Additional Information
Dr. Brenda M. Sandmaier
Fred Hutchinson Cancer Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place