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Phase II Study of Allogeneic Peripheral Blood Stem Cell Transplantation With Pre-Conditioning Low-Dose Total Body Irradiation and Fludarabine Followed By Mycophenolate Mofetil and Cyclosporine in Elderly Patients With Acute Myeloid Leukemia in First Complete Remission
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Completed | 55 to 69 | SWOG-S0125
S0125, NCT00053014 |
Objectives - Determine whether allogeneic peripheral blood stem cell transplantation with pre-conditioning low dose total body irradiation and fludarabine followed by cyclosporine and mycophenolate mofetil, when given to elderly patients with acute myeloid leukemia in first complete remission, is sufficiently efficacious (in terms of survival 1 year after transplantation) to warrant a phase III investigation.
- Determine the frequency and severity of toxic effects of this regimen in these patients.
- Determine whether chimerism patterns in bone marrow and blood after transplantation are associated with relapse and/or graft-versus-host disease (GVHD) in these patients.
- Determine whether cytogenic, immunophenotypic, and molecular biologic features detected in pre- and post-transplantation specimens are related to transplant outcomes and risk of relapse in these patients.
Entry Criteria Disease Characteristics:
- Morphologically confirmed acute myeloid leukemia (AML) (within 180 days of diagnosis)
OR - Secondary AML (secondary to myelodysplastic syndromes (MDS) or to prior leukemogenic therapy)
- Must have A1 marrow, B1 blood, and C1 extramedullary disease status
- Must have received prior remission induction chemotherapy
- Must have a genotypically HLA-identical sibling donor available that is not a monozygotic identical twin
- No M3 AML or blastic transformation of chronic myelogenous leukemia
- If history of CNS leukemia, no leukemia cells in CNS by lumbar puncture within past 7 days
- Must be concurrently enrolled on protocols SWOG-9007 and SWOG-S9910
Prior/Concurrent Therapy:
Biologic therapy - No prior allogeneic hematopoietic stem cell transplantation
Chemotherapy - See Disease Characteristics
- Prior consolidation therapy allowed
Endocrine therapy Radiotherapy Surgery - Prior organ transplantation allowed provided not concurrently receiving immunosuppressive therapy
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - See Disease Characteristics
Hepatic Renal Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No other malignancy within the past 2 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Adequately treated stage I or II cancer in complete remission
Expected Enrollment A total of 25-51 patients will be accrued for this study. Outline This is an open-label study. - Conditioning regimen: Patients receive fludarabine IV over 1 hour on days -4 to -2. Patients also undergo total body irradiation on day 0.
- Peripheral blood stem cell infusion (PBSC): Patients receive unmodified filgrastim transplantation (G-CSF)-mobilized donor PBSC on day 0.
- Post-transplantation immunosuppression: Patients receive oral cyclosporine on days -3 to 35 followed by a taper until day 180. Patients also receive oral mycophenolate mofetil on day 0 to 27 without tapering.
- Donor lymphocyte infusions (DLI): Patients with relapsed disease receive DLI IV over 30 minutes for up to 2 infusions.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
Trial Contact Information
Trial Lead Organizations Southwest Oncology Group | | | | Peter McSweeney, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study) | | | Trial Start Date | | 2003-04-01 | | | Registered in ClinicalTrials.gov | | NCT00053014 | | | Date Submitted to PDQ | | 2002-11-14 | | | Information Last Verified | | 2005-04-26 | | | NCI Grant/Contract Number | | CA32101 |
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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