Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against normal tissues. Methotrexate and cyclosporine may prevent this from happening.
PURPOSE: Phase III trial to study the effectiveness of treatment with methotrexate and cyclosporine after bone marrow transplantation to provide protection against acute graft-versus-host disease.
|Graft Versus Host Disease Leukemia Lymphoma||Drug: cyclosporine Drug: methotrexate Procedure: allogeneic bone marrow transplantation||Phase 3|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease|
|Study Start Date:||May 1986|
|Study Completion Date:||April 2002|
OBJECTIVES: I. Determine the efficacy of a combination of methotrexate and cyclosporine, administered after grafting, to prevent the development of acute graft versus host disease (GVHD) in patients undergoing allogeneic bone marrow transplantation.
OUTLINE: Patients receive methotrexate IV on days 1,3,6, and 11. Patients also receive cyclosporine IV twice a day until the patient is eating, then it is administered orally twice a day. Cyclosporine begins on day -1 and continues until day 180. The dose is reduced beginning on day 50.
PROJECTED ACCRUAL: Accrual will continue until further notice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002456
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||Rainer F. Storb, MD||Fred Hutchinson Cancer Research Center|