S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute myeloid leukemia in remission, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities
Eligibility 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 PATIENT CHARACTERISTICS: Age 55 to 69 Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Not specified Renal Not specified 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 PRIOR CONCURRENT THERAPY: Biologic therapy No prior allogeneic hematopoietic stem cell transplantation Chemotherapy See Disease Characteristics Prior consolidation therapy allowed Endocrine therapy Not specified Radiotherapy Not specified Surgery Prior organ transplantation allowed provided not concurrently receiving immunosuppressive therapy
Sites / Locations
- Banner Good Samaritan Medical Center
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock
- City of Hope Comprehensive Cancer Center
- Scripps Cancer Center at Scripps Clinic
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center at UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Sutter Cancer Center
- University of California Davis Cancer Center
- Stanford Cancer Center at Stanford University Medical Center
- General Robert Huyser Cancer Center at David Grant Medical Center
- John Muir/Mt. Diablo Comprehensive Cancer Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- Veterans Affairs Medical Center - Tampa (Haley)
- CCOP - Atlanta Regional
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- MBCCOP - Hawaii
- Mountain States Tumor Institute - Boise
- Veterans Affairs Medical Center - Chicago Westside Hospital
- Veterans Affairs Medical Center - Hines
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Indiana Blood and Marrow Transplantation
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Veterans Affairs Medical Center - New Orleans
- New Orleans Cancer Institute at Memorial Medical Center
- Veterans Affairs Medical Center - Shreveport
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Massachusetts General Hospital Cancer Center
- Cancer Research Center at Boston Medical Center
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Josephine Ford Cancer Center at Henry Ford Health System
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- CCOP - Kansas City
- Saint Louis University Cancer Center
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- Veterans Affairs Medical Center - Albany
- NYU Cancer Institute at New York University Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Veterans Affairs Medical Center - Cincinnati
- Cleveland Clinic Taussig Cancer Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma University Medical Center
- Veterans Affairs Medical Center - Oklahoma City
- Cancer Institute at Oregon Health and Science University
- CCOP - Columbia River Oncology Program
- Veterans Affairs Medical Center - Charleston
- CCOP - Greenville
- University of Tennessee Cancer Institute at Methodist Central Hospital
- Veterans Affairs Medical Center - Amarillo
- Baylor College of Medicine
- Wilford Hall Medical Center
- UMC Southwest Cancer and Research Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- Huntsman Cancer Institute at University of Utah
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Veterans Affairs Medical Center - Seattle
- Fred Hutchinson Cancer Research Center
- CCOP - Northwest
- Madigan Army Medical Center
Arms of the Study
Arm 1
Experimental
treatment
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