Comparing Anti-CD25 Monoclonal Antibody and Methotrexate to Prevent Acute Graft-Versus-Host Disease After Haploidentical Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating two different strategies to prevent acute graft-versus-host disease GVHD in patients with blood cancers who are undergoing haploidentical hematopoietic stem cell transplantation. This Phase III clinical trial compares an anti-CD25 monoclonal antibody regimen with the commonly used methotrexate-based prophylaxis. The study aims to improve 12-month graft-versus-host disease-free, relapse-free survival and reduce complications associated with current treatments. Participants will be randomly assigned to one of two groups. One group will receive methotrexate intravenously on Days 1, 3, 6, and 11 after transplantation along with standard GVHD prophylaxis including anti-thymocyte globulin, calcineurin inhibitor, and mycophenolate mofetil. The other group will receive anti-CD25 monoclonal antibody intravenously on Day 0 two hours before stem cell infusion and Day 4, alongside the same standard prophylaxis. Both treatment plans are designed to prevent GVHD following the transplantation. Throughout the study, participants will be monitored for outcomes such as acute and chronic GVHD, oral mucositis, hematopoietic recovery, viral reactivation, infection, relapse, and survival. The main measure is the graft-versus-host disease-free, relapse-free survival at 12 months post-transplant. Patients will undergo regular assessments to track these outcomes during the year following transplantation to evaluate the safety and efficacy of the two prophylaxis approaches.

Anti-CD25 Monoclonal Antibody for Prevention of Acute GVHD After Haploidentical HSCT