NCT00002456

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Graft Versus Host Disease
• Leukemia
• Lymphoma

Interventions

Type	Name	Description
DRUG	cyclosporine
DRUG	methotrexate
PROCEDURE	allogeneic bone marrow transplantation

Timeline

• Start date: 1986-05-01
• Completion: 2002-04-01
• First posted: 2004-04-26
• Last updated: 2011-11-30

Locations

1 site across 1 country: United States