S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
- Conditions
- Myelodysplastic SyndromesLeukemia
- Interventions
- Procedure: allogeneic bone marrow transplantationRadiation: radiation therapy
- Registration Number
- NCT00005866
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known if total-body irradiation plus peripheral stem cell transplantation is more effective with busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of busulfan with that of cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.
- Detailed Description
OBJECTIVES: I. Compare event free survival after total body irradiation (TBI) plus busulfan versus TBI plus cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia. II. Determine the distribution of pharmacokinetic parameters for busulfan in those patients randomized to the busulfan treatment arm. III. Investigate the prognostic significance for event free survival of prior history of red cell transfusions, cytogenetic pattern, and of functional drug resistance at diagnosis in these patients. IV. Estimate the frequencies of cytogenetic and genetic changes during disease progression in these patients.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to age (40 and under vs 41-55) and diagnosis and International Prognostic Scoring System (IPSS) risk group (myelodysplastic syndrome (MDS)/IPSS - intermediate 1 vs MDS/IPSS - intermediate 2 vs MDS/IPSS high risk vs MDS related acute myeloid leukemia). Patients are randomized to one of two treatment arms. Arm I: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses. Arm II: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients receive total body irradiation (TBI) twice a day on days -3 to -1; peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0; cyclosporine IV every 12 hours on days -1 to 60, and then tapering in the absence of graft versus host disease; and methotrexate IV on days 1, 3, 6, and 11. Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study over 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment allogeneic bone marrow transplantation - treatment cyclophosphamide - treatment cyclosporine - treatment radiation therapy - treatment busulfan - treatment methotrexate -
- Primary Outcome Measures
Name Time Method Event-free survival every 6 months after stem cell infusion until death or 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (66)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Northern California Cancer Specialists Medical Clinic
🇺🇸Walnut Creek, California, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
St. Francis Medical Center
🇺🇸Honolulu, Hawaii, United States
Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Lucille Parker Markey Cancer Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Louisiana State University School of Medicine
🇺🇸New Orleans, Louisiana, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Cancer Research Center
🇺🇸Boston, Massachusetts, United States
St. John's Health System
🇺🇸Springfield, Missouri, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Jewish Hospital of Cincinnati, Inc.
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Wilford Hall - 59th Medical Wing
🇺🇸Lackland Air Force Base, Texas, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Scott and White Clinic
🇺🇸Temple, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Cancer Center of Kansas - Wichita
🇺🇸Wichita, Kansas, United States
Health Science Center
🇺🇸Lubbock, Texas, United States
Memorial Medical Center
🇺🇸New Orleans, Louisiana, United States
St. Joseph Hospital - Orange
🇺🇸Orange, California, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Franciscan Health System
🇺🇸Tacoma, Washington, United States
Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Cancer Center
🇺🇸Portland, Oregon, United States
Legacy Cancer Services
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Methodist Health Care System
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States