S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.
|Leukemia||Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||S0125, 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)|
- Overall Survival [ Time Frame: 1 year ]measured from date of registration to study until death from any cause with patients still alive censored at date of last contact
- Serious Adverse Events [ Time Frame: 9 months ]Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.
|Study Start Date:||April 2003|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - cyclosporine 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); mycophenolate mofetil 15mg/kg bid PO D0 to +27
Biological: therapeutic allogeneic lymphocytes
Drug: mycophenolate mofetil
Other Name: MMFProcedure: peripheral blood stem cell transplantation Radiation: radiation therapy
- 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.
Other objectives as funding permits:
- 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.
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.
PROJECTED ACCRUAL: A total of 25-51 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053014
Show 83 Study Locations
|Study Chair:||Peter McSweeney, MD||Rocky Mountain Cancer Centers - Denver Midtown|