A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
The primary objective of the trial is to compare 18 month overall survival rates of the two groups of patients starting from the time of randomization to the RIC or MAC arms.
18 months
No
Bart Scott, MD
Study Chair
Fred Hutchinson Cancer Research Center
United States: Federal Government
709
NCT01339910
May 2011
November 2017
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Mount Sinai Medical Center | New York, New York 10029 |
Baylor University Medical Center | Dallas, Texas 75246 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Emory University | Atlanta, Georgia 30322 |
University of Wisconsin Hospital & Clinics | Madison, Wisconsin 53792 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Texas Transplant Institute | San Antonio, Texas 78229 |
University of California, San Diego Medical Center | San Diego, California |
Tufts Medical Center | Boston, Massachusetts 02111 |
University Hospitals of Cleveland/Case Western | Cleveland, Ohio 44106 |
University of Oklahoma Medical Center | Oklahoma City, Oklahoma 73104 |
Baylor College of Medicine/The Methodist Hospital | Houston, Texas 77030-2399 |
Utah BMT/University of Utah Medical School | Salt Lake City, Utah 84132 |
Blood and Marrow Transplant Program at Northside Hospital | Atlanta, Georgia 30342 |
University of North Carolina Hospital at Chapel Hill | Chapel Hill, North Carolina 27599 |
West Virginia University Hospital | Morgantown, West Virginia 26506-9162 |
University of Florida College of Medicine | Gainesville, Florida 32610 |
University Of Kansas | Kansas City, Kansas 66160 |
Jewish Hospital BMT Program | Cincinnati, Ohio 45236 |
DFCI, Brigham & Women's Hospital | Boston, Massachusetts 02114 |