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Phase III Randomized Study of FK506 vs CYSP as GVHD Prophylaxis Following Allogeneic Bone Marrow Transplantation (Summary Last Modified 05/94)
Basic Trial Information
Objectives I. Assess the efficacy and safety of FK506 vs. cyclosporine (both administered with a standard short course of methotrexate) in the prevention of graft-versus-host disease after an allogeneic bone marrow transplant from a genotypically HLA-identical sibling donor. Entry Criteria Disease Characteristics: Malignancy for which an allogeneic bone marrow transplant (BMT) from a sibling donor is planned Patient-donor HLA-identical genotype required No T-cell depleted BMT Prior/Concurrent Therapy: No prior transplants Patient Characteristics: Age: 12 and older Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 3.0 mg/dl Other: No known hypersensitivity to Cremophor or related products No known carrier of HIV viruses No pregnant or nursing women Negative pregnancy test required unless surgically sterile Effective birth control required of fertile patients receiving FK506 Expected Enrollment 300 evaluable patients will be studied at 10-20 centers. Outline Randomized study. Patients are randomized prior to allogeneic bone marrow transplantation (BMT). Arm I: GVHD Prophylaxis. FK506; with Methotrexate, MTX, NSC-740. Arm II: GVHD Prophylaxis. Cyclosporine, CYSP, NSC-290193; with MTX. Trial Lead Organizations Barbara Ann Karmanos Cancer Institute
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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