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
NCT ID: NCT00005866
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2000-02-29
2006-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment
busulfan
arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4
cyclophosphamide
arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4
cyclosporine
both arms per published schedule
methotrexate
GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV
allogeneic bone marrow transplantation
day 0
radiation therapy
both arms: 1200 cGy total dose (6 x 200 fractions)
Interventions
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busulfan
arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4
cyclophosphamide
arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4
cyclosporine
both arms per published schedule
methotrexate
GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV
allogeneic bone marrow transplantation
day 0
radiation therapy
both arms: 1200 cGy total dose (6 x 200 fractions)
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No prior malignancy within past 5 years except: 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 HIV negative Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No autologous peripheral stem cell transplantation prior to diagnosis of myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia Chemotherapy: No prior chemotherapy for MDS or MDS related acute myeloid leukemia except oral chemotherapy to control leukocytosis or thrombocytosis (e.g., hydroxyurea or etoposide) Endocrine therapy: Not specified Radiotherapy: No radiotherapy prior to diagnosis of MDS or MDS related acute myeloid leukemia Surgery: Not specified
16 Years
55 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Jeanne E. Anderson, MD
Role: STUDY_CHAIR
Katmai Oncology Group
Locations
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Good Samaritan Medical Center
Phoenix, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 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
St. Joseph Hospital - Orange
Orange, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Stanford University Medical Center
Stanford, California, United States
Northern California Cancer Specialists Medical Clinic
Walnut Creek, California, United States
University of Colorado Cancer Center
Denver, Colorado, 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
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 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
Memorial Medical Center
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
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 Mississippi Medical Center
Jackson, Mississippi, United States
St. John's Health System
Springfield, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, 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
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
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
Health Science Center
Lubbock, Texas, 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
CCOP - Scott and White Hospital
Temple, Texas, United States
Scott and White Clinic
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 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
Franciscan Health System
Tacoma, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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S9920
Identifier Type: OTHER
Identifier Source: secondary_id
S9920
Identifier Type: -
Identifier Source: org_study_id
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