Twenty-Year Follow-Up of a Controlled Trial Comparing a Combination of Methotrexate Plus Cyclosporine with Cyclosporine Alone for Prophylaxis of Graft-versus-Host Disease in Patients Administered HLA-Identical Marrow Grafts for Leukemia

Between August 9, 1983, and April 10, 1985, we conducted a controlled trial that compared the safety and efficacy of a combination of methotrexate plus cyclosporine with cyclosporine alone for preventing acute graft-versus-host disease (GVHD) in 93 patients administered HLA-identical sibling marrow grafts for the treatment of acute myelogenous leukemia (AML; n = 48) in first remission and chronic myelocytic leukemia (CML; n = 45) in chronic phase [1]. We found that methotrexate/cyclosporine-treated patients had less grade II to III acute GVHD (32% versus 59%; P = .01) compared with cyclosporine-treated patients, and no patient given the combination developed grade IV acute GVHD, compared with 7 cyclosporine-treated patients.