Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
one year
No
Paulo V Campregher, MD
Principal Investigator
Hospital Israelita Albert Einstein
Brazil: Agência Nacional de Vigilância Sanitária
GEDECH-2012
NCT01749111
December 2012
December 2017
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