A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
I. Determine whether the conditioning intensity affects outcomes after HCT in patients with
MDS or AML who have < 5% marrow myeloblasts at the time of HCT.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I (Nonmyeloablative regimen):
CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo
low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3
to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper
on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days
0-27 or every 8 hours on days 0-40 with taper on days 41-96.
Arm II (Myeloablative regimen):
CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or
busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral
busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally
every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate
IV on days 1, 3, 6, and 11.
Treatment in both arms continues in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up periodically.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
At 2 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|University of Utah||Salt Lake City, Utah|
|Emory University||Atlanta, Georgia 30322|
|Veterans Administration Center-Seattle||Seattle, Washington 98108|
|HealthOne Presbyterian St. Lukes Medical Center||Denver, Colorado|
|Weill Cornell University||New York, New York 10021|
|Medical College Wisconsin||Milwaukee, Wisconsin|