Evaluating Cyclophosphamide to Prevent Graft Versus Host Disease in Matched Unrelated Donor Stem Cell Transplant for Blood Cancers

What this Trial Is About

Researchers are evaluating the clinical effectiveness of cyclophosphamide compared to antihuman T-lymphocyte immune globulin ATG in patients undergoing bone marrow transplants from matched unrelated donors for hematological malignancies. The study aims to measure overall survival, progression-free survival, and the incidence of both acute and chronic graft versus host disease GvHD. This is a prospective randomized controlled trial conducted by Hospital Israelita Albert Einstein involving patients aged 1 to 75 years. Participants will be randomly assigned to one of two treatment groups. One group will receive cyclophosphamide at 50 mgkg on days 3 and 4, followed by a calcineurin inhibitor and mycophenolate mofetil starting on day 5 until day 35. The other group will receive thymoglobulin ATG at a total dose of 5 mgkg from days -4 to -1, along with a calcineurin inhibitor starting on day 5 and methotrexate on days 1, 3, 6, and 11. These treatments are studied as strategies to prevent graft versus host disease after transplantation. During the study, researchers will assess overall survival over four years as the primary outcome. Secondary outcomes include progression-free survival, acute and chronic graft versus host disease occurrences, and treatment-related mortality, all monitored over the same period. Participants will undergo regular evaluations to monitor these outcomes and ensure safety. The total duration of participant involvement may extend up to four years to capture long-term results.

Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies