Spots Global Cancer Trial Database for Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis

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Trial Identification

Brief Title: Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis

Official Title: Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis

Study ID: NCT01749111

Conditions

Acute Myelogenous Leukemia

Acute Lymphoid Leukemia

Myeloproliferative Disease

Myelodysplastic Syndrome

Chronic Myeloid Leukemia

Chronic Myelomonocytic Leukemia

Interventions

ARM A Cyclophosphamide

ARM B Calcineurin inhibitor and methotrexate

Study Description

Brief Summary: The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor

Detailed Description: We propose a study in which 150 patients will receive graft versus host disease prophylaxis with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and 150 patients will receive the usual combination of methotrexate and calcineurin inhibitor. The study was designed to last for 4 years. The primary endpoint is the rate of patients alive, in remission and without immunosuppression, one year after transplant. The assignment for each arm of the study will be done through simple randomization.