Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
- Conditions
- Graft Versus Host DiseaseLeukemiaLymphoma
- Registration Number
- NCT00002456
- Lead Sponsor
- Fred Hutchinson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States