Spots Global Cancer Trial Database for Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation

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Trial Identification

Brief Title: Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation

Official Title: Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease

Study ID: NCT00002456

Conditions

Graft Versus Host Disease

Leukemia

Lymphoma

Interventions

cyclosporine

methotrexate

allogeneic bone marrow transplantation

Study Description

Brief Summary: 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.

Detailed Description: 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.