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Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4

In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis

Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation

ARM A Cyclophosphamide

Graft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate

ARM B Calcineurin inhibitor and methotrexate

Paulo V Campregher, MD

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

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.

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

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

Cumulative incidence of disease relapse, one year after bone marrow transplantation

The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.

Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation

Hospital Israelita Albert Einstein

Spots Global Cancer Trial Database for arm b calcineurin inhibitor and methotrexate