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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02247 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2430.00 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P01CA078902 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies the side effects and how well clofarabine works when given together with low-dose total-body irradiation (TBI) in treating patients with acute myeloid leukemia (AML) undergoing donor peripheral blood stem cell transplant (PBSCT). Giving chemotherapy and TBI before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of clofarabine in combination with 2, 3, or 4 Gy TBI in preparation for hematopoietic cell transplantation (HCT) from human leukocyte antigen (HLA)-identical related and HLA-matched unrelated donors in patients with AML. (Part 1)
II. To determine the efficacy of the maximum tolerated dose of clofarabine combined with 2, 3, or 4 Gy TBI in reducing the 6 month relapse rate in patients with AML compared to our historical experience with fludarabine and 2 Gy TBI. A satisfactory improvement will be considered 6 month relapse rate declines from 35% to 20% among high-risk (objective for low risk group terminated August 2014). (Part 2)
SECONDARY OBJECTIVES:
I. Leukemia-free and overall survivals.
II. Non-relapse mortality (NRM) of < 5% at 100 days.
III. Engraftment rate of >= 95%.
IV. Prognostic significance of cytogenetics and genetic markers not detected by traditional karyotype analysis, with special respect to tyrosine kinase receptor mutations (such as fms-like tyrosine kinase 3 [FLT3]), retrovirus-associated deoxyribonucleic acid (DNA) sequences (RAS)- and nucleophosmin gene mutations along with CCAAT/enhancer binding protein, alpha (C/EBP) mutations.
V. Rigorous monitoring for minimal residual/recurring disease by standard morphologic, flow cytometric, and molecular techniques in order to facilitate early intervention.
VI. To evaluate the pharmacokinetics of clofarabine (pharmacokinetic samples discontinued January 2017).
OUTLINE: This is a dose-escalation study of clofarabine.
CONDITIONING REGIMEN: Patients receive clofarabine intravenously (IV) over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine orally (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.
After completion of study treatment, patients are followed up at 4 months and then every year thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - Dose 1 (30 mg/m^2 Clofarabine) | Experimental | 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) | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Undergo allogeneic hematopoietic PBSCT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicities (DLT) | 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. | 14 days post-transplant |
| Part 2: Number of Participants With Relapsed Disease | 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. | 6 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Surviving Progression-free. | 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. | 1 Year post-transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenda Sandmaier | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| Ochsner Medical Center Jefferson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31637757 | Result | Krakow EF, Gyurkocza B, Storer BE, Chauncey TR, McCune JS, Radich JP, Bouvier ME, Estey EH, Storb R, Maloney DG, Sandmaier BM. Phase I/II multisite trial of optimally dosed clofarabine and low-dose TBI for hematopoietic cell transplantation in acute myeloid leukemia. Am J Hematol. 2020 Jan;95(1):48-56. doi: 10.1002/ajh.25665. Epub 2019 Nov 8. | |
| 32499241 | Derived | Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2017 |
Not provided
In part 1, patients are treated at each dose in cohorts of three and observed for any dose limiting toxicities. In Part 2, patients are treated at the maximum tolerated dose established in Part 1.
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|
| Part 1 - Dose 3 (50 mg/m^2 Clofarabine) | Experimental | 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) | Experimental | 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) | Experimental | 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) | Experimental | 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 |
|
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| Clofarabine | Drug | Given IV |
|
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| Cyclosporine | Drug | Given PO |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Mycophenolate Mofetil | Drug | Given PO |
|
|
| Peripheral Blood Stem Cell Transplantation | Procedure | Undergo allogeneic hematopoietic PBSCT |
|
|
| Pharmacological Study | Other | Optional correlative studies |
|
| Total-Body Irradiation | Radiation | Undergo TBI |
|
|
| Number of Participants Surviving Overall |
Number of patients surviving overall post-transplant. |
| 1 Year post-transplant |
| Number of Non-Relapse Mortalities (NRM) | Number of patients who expired without disease progression/relapse. | 100 days post-transplant |
| Number of Participants Who Graft Rejected. | Number of patients who graft rejected post-transplant. Graft rejection is defined as <5% donor peripheral blood T cells (CD3+). | 1 Year post-transplant. |
| Prognostic Significance of Cytogenetic and Genetic Markers | Potential prognostic markers will be assessed by polymerase chain reaction (PCR) to determine their prognostic value. | 1 Year post-transplant |
| Number of Participants With Minimal Residual/Recurring Disease (MRD) Post-transplant | Number of patients with MRD post-transplant, detected in the bone marrow as cytogenetic abnormalities or <5% monoclonal blasts by flow cytometry. | 1 Year post-transplant |
| Pharmacokinetics (PK) of Clofarabine | 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. | 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. |
| New Orleans |
| Louisiana |
| 70121 |
| United States |
| VA Puget Sound Health Care System | Seattle | Washington | 98101 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| FG005 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Number of Participants With Dose Limiting Toxicities (DLT) | 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. | Analysis only applies to subjects accrued in Part 1 of the study. | Posted | Count of Participants | Participants | 14 days post-transplant |
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|
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| Primary | Part 2: Number of Participants With Relapsed Disease | 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. | 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. | Posted | Count of Participants | Participants | 6 months post-transplant |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Surviving Progression-free. | 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. | No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1. | Posted | Count of Participants | Participants | 1 Year post-transplant |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Surviving Overall | Number of patients surviving overall post-transplant. | No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1. | Posted | Count of Participants | Participants | 1 Year post-transplant |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Non-Relapse Mortalities (NRM) | Number of patients who expired without disease progression/relapse. | No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1. | Posted | Count of Participants | Participants | 100 days post-transplant |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Graft Rejected. | Number of patients who graft rejected post-transplant. Graft rejection is defined as <5% donor peripheral blood T cells (CD3+). | 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. | Posted | Count of Participants | Participants | 1 Year post-transplant. |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Prognostic Significance of Cytogenetic and Genetic Markers | Potential prognostic markers will be assessed by polymerase chain reaction (PCR) to determine their prognostic value. | The studies have not been carried out on the specimens to evaluate this outcome measure. | Posted | 1 Year post-transplant |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Minimal Residual/Recurring Disease (MRD) Post-transplant | Number of patients with MRD post-transplant, detected in the bone marrow as cytogenetic abnormalities or <5% monoclonal blasts by flow cytometry. | 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. | Posted | Count of Participants | Participants | 1 Year post-transplant |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) of Clofarabine | 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. | Pharmacokinetic analyses were performed on only a subset of patients. | Posted | Number | L/h/kg | 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. |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 3 | 3 | 0 | 3 | 2 | 3 |
| EG001 | 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 | 1 | 3 | 0 | 3 | 1 | 3 |
| EG002 | 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 | 2 | 3 | 0 | 3 | 1 | 3 |
| EG003 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | 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 | 13 | 35 | 0 | 35 | 18 | 35 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Cardiac troponin I increased | Investigations | Systematic Assessment |
| ||
| Constrictive pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Device related infection | Infections and infestations | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Weight gain | Investigations | Systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brenda M. Sandmaier | Fred Hutchinson Cancer Research Center | (206) 667-4961 | bsandmai@fredhutch.org |
| Jan 8, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
|
|
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 |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
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| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
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| 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 |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
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| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
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| OG001 |
| 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 |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
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| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
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