A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia
- Compare the efficacy of processed (cell depleted) vs unprocessed (conventional)
unrelated bone marrow transplantation in reducing grade III/IV acute graft vs host
disease (GVHD) in patients with acute or chronic leukemia or myelodysplastic syndromes.
- Compare the safety of these regimens in these patients.
- Compare the disease-free survival rate at 100 days and at 6 months in patients treated
with these regimens.
- Compare the time to engraftment and percent engraftment in patients treated with these
- Compare the reduction rate of grade II or greater acute and chronic GVHD in patients
treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to degree of HLA matching and disease (chronic vs acute). Acute myelogenous
leukemia patients are further stratified according to prior myelodysplastic syndromes (yes
vs no). Patients are randomized to one of two bone marrow transplantation arms.
All patients receive a conditioning regimen comprising fludarabine IV on day -6,
cyclophosphamide IV on days -5 and -4, anti-thymocyte globulin IV on days -4 and -2, and
total body irradiation on days -3 to 0. Patients also receive methylprednisolone IV every 12
hours for 4 doses on days -2 to 0. Tacrolimus IV is administered continuously on day -1 and
continues either orally or IV for 6 months. Bone marrow is infused on day 0. Filgrastim
(G-CSF) is administered subcutaneously from day 0 until blood counts recover.
- Arm I: Patients receive allogeneic bone marrow that has been processed to produce a
mononuclear cell preparation.
- Arm II: Patients receive unprocessed allogeneic bone marrow. Patients are followed
weekly for 100 days and then at 6 months.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 17 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
James N. Lowder, MD
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|University of Rochester Cancer Center||Rochester, New York 14642|
|Shands Hospital and Clinics, University of Florida||Gainesville, Florida 32610-100277|
|University of California San Diego Cancer Center||La Jolla, California 92093-0658|
|Hahnemann University Hospital||Philadelphia, Pennsylvania 19102-1192|
|Lombardi Cancer Center||Washington, District of Columbia 20007|
|James Graham Brown Cancer Center||Louisville, Kentucky 40202|
|New York Medical College||Valhalla, New York 10595|
|Massey Cancer Center||Richmond, Virginia 23298-0037|
|Oregon Cancer Center||Portland, Oregon 97201-3098|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|Presbyterian-St Luke's Medical Center||Denver, Colorado 80218|
|South Texas Cancer Institute||San Antonio, Texas 78229|
|Indiana Blood and Marrow Transplantation||Indianapolis, Indiana 46202|