Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.
|Graft Versus Host Disease Leukemia Myelodysplastic Syndromes||Biological: anti-thymocyte globulin Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Drug: methylprednisolone Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation Radiation: radiation therapy||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||March 2000|
|Study Completion Date:||May 2003|
- 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 regimens.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004255
|United States, California|
|University of California San Diego Cancer Center|
|La Jolla, California, United States, 92093-0658|
|United States, Colorado|
|Presbyterian-St Luke's Medical Center|
|Denver, Colorado, United States, 80218|
|United States, District of Columbia|
|Lombardi Cancer Center|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|Shands Hospital and Clinics, University of Florida|
|Gainesville, Florida, United States, 32610-100277|
|United States, Indiana|
|Indiana Blood and Marrow Transplantation|
|Indianapolis, Indiana, United States, 46202|
|United States, Kentucky|
|James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, New York|
|University of Rochester Cancer Center|
|Rochester, New York, United States, 14642|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73190|
|United States, Oregon|
|Oregon Cancer Center|
|Portland, Oregon, United States, 97201-3098|
|United States, Pennsylvania|
|Hahnemann University Hospital|
|Philadelphia, Pennsylvania, United States, 19102-1192|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|South Texas Cancer Institute|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||James N. Lowder, MD||Chimeric Therapies|