Spots Global Cancer Trial Database for Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)
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Trial Identification
Brief Title: Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)
Official Title: A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (BMT CTN #0901)
Study ID: NCT01339910
Conditions
Study Description
Brief Summary: The study is designed as a Phase III, multicenter trial comparing outcomes after allogeneic hematopoietic stem cell transplantation (HCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) between patients receiving myeloablative conditioning (MAC) versus reduced intensity conditioning (RIC) regimens.
Detailed Description: Patients randomized to RIC will receive one of two regimen types: the combination of fludarabine (120-180 mg/m\^2) and busulfan (less than or equal to 8 mg/kg or IV equivalent) (Flu/Bu) or fludarabine (120-180 mg/m\^2) and melphalan (less than 150 mg/m\^2) (Flu/Mel). Patient randomized to MAC will receive one of three regimens: busulfan (16 mg/kg oral or 12.8 mg/kg IV equivalent) and cyclophosphamide (120 mg/kg) (Bu/Cy); or, busulfan (16 mg/kg PO or 12.8 mg/kg IV) and fludarabine (120-180 mg/m\^2) (Bu/Flu); or, cyclophosphamide (120 mg/kg) and total body irradiation (greater than 1200-1420cGy) (CyTBI). A total of 356 patients (178 to each arm) will be accrued on this study over a period of four years. Patients will be followed for up to 18 months from transplantation.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Phoenix, Phoenix, Arizona, United States
University of California, San Diego Medical Center, La Jolla, California, United States
University of Florida College of Medicine, Gainesville, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Blood and Marrow Transplant Program at Northside Hospital, Atlanta, Georgia, United States
University of Kansas, Kansas City, Kansas, United States
University of Kentucky, Lexington, Kentucky, United States
DFCI, Brigham & Women's Hospital, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University/Barnes Jewish Hospital, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Mount Sinai Medical Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
University of North Carolina Hospital at Chapel Hill, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Jewish Hospital BMT Program, Cincinnati, Ohio, United States
University Hospitals of Cleveland/Case Western, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Baylor University Medical Center, Dallas, Texas, United States
Texas Transplant Institute, San Antonio, Texas, United States
Utah BMT/University of Utah Medical School, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
West Virginia University Hospital, Morgantown, West Virginia, United States
University of Wisconsin Hospital & Clinics, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Mary Horowitz, MD
Affiliation: Center for International Blood and Marrow Transplant Research
Role: STUDY_DIRECTOR
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