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Phase II Study of a Nonmyeloablative Preparative Regimen Comprising Fludarabine and Busulfan Followed By Allogeneic Stem Cell Transplantation in Older Patients With Acute Myeloid Leukemia in First Morphologic Complete Remission
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
Basic Trial Information
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Status
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Age
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Protocol IDs
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Phase II
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Treatment
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Temporarily closed
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60 to 74
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NCI
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CALGB-100103 NCT00070135
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Objectives Primary - Determine whether allogeneic stem cell transplantation from a matched sibling or unrelated donor using a nonmyeloablative preparative regimen comprising fludarabine and busulfan results in a 2-year disease-free survival that is better than historical results using standard chemotherapy in older patients with acute myeloid leukemia in first morphologic complete remission.
Secondary - Determine the 2-year actuarial risks of transplant-related mortality, acute and chronic graft-versus-host disease, and relapse in patients treated with this regimen.
- Determine the recovery of T- and B-cell number and function and the time course of T, B, and myeloid progenitor chimerism in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
Entry Criteria Disease Characteristics:
- Diagnosis of acute myeloid leukemia (AML) in first morphologic complete remission
- No FAB M3 disease
- Preceding myelodysplastic syndromes and treatment-related AML allowed
- Morphologic complete remission achieved within the past 6 months and after no more than 2 courses of induction chemotherapy
- No more than 2 courses of prior consolidation therapy
- Any consolidation regimen that does not require transplantation allowed
- No acute leukemia after blast transformation of prior chronic myelogenous leukemia or other myeloproliferative disease
- Prior CNS involvement allowed provided the disease is in remission at time of transplantation
- The following donors will be allowed:
- Available HLA-identical (6/6) sibling donor by serological typing (A, B, DR)
- Locus matched unrelated donor (10/10) by high resolution molecular typing (HLA-A, -B, -C, -DRB1, and -DQB1).
- No syngeneic donors
Prior/Concurrent Therapy:
Biologic therapy - See Disease Characteristics
Chemotherapy - See Disease Characteristics
- At least 4 weeks since prior chemotherapy
Endocrine therapy Radiotherapy - At least 4 weeks since prior radiotherapy
Surgery - At least 4 weeks since prior surgery
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - See Disease Characteristics
Hepatic - Bilirubin less than 2 mg/dL*
- Bilirubin 2-3 mg/dL with normal direct bilirubin allowed
- AST less than 3 times upper limit of normal*
[Note: *Unless attributable to disease] Renal - Creatinine clearance at least 40 mL/min (unless attributable to disease)
Cardiovascular - LVEF at least 30% by MUGA or ECHO
Pulmonary - DLCO greater than 40%
- No symptomatic pulmonary disease
Other - Not pregnant
- Fertile patients must use effective contraception
- HIV negative
- No uncontrolled diabetes mellitus
- No active serious infection requiring antibiotics
- No known hypersensitivity to E. coli-derived products
Expected Enrollment 61A total of 61 patients will be accrued for this study. Outcomes Primary Outcome(s)Progression-free survival at 2 years
Outline This is a multicenter study. - Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral or IV tacrolimus twice daily starting on days -2, with tapering between days 90-120, and stopping by days 150-180. Patients also receive methotrexate IV on days 1, 3, 6,and 11 and rabbit antithymocyte globulin (Thymoglobulin) IV
over 4-6 hours on days -4 through -2.
- Allogeneic peripheral blood stem cell transplantation (PBSC): Patients undergo allogeneic PBSC transplantation on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 12 and continuing until blood counts recover. Patients with progressive disease will be removed from the study and may receive additional treatment at the discretion of the
investigator.
Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months for 3 years.
Trial Contact Information
Trial Lead Organizations Cancer and Leukemia Group B | | | Steven Devine, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen | | Trial Start Date | | 2004-01-15 | | Trial Completion Date | | 2005-04-16 (estimated) | | Registered in ClinicalTrials.gov | | NCT00070135 | | Date Submitted to PDQ | | 2003-08-14 | | Information Last Verified | | 2009-01-21 | | NCI Grant/Contract Number | | CA31946 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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