Acute graft-versus-host disease remains a major complication after haploidentical hematopoietic stem cell transplantation. Methotrexate is commonly used as part of graft-versus-host disease prophylaxis, but it may be associated with delayed hematopoietic recovery and transplant-related toxicities, including oral mucositis.
This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase III clinical trial designed to evaluate an anti-CD25 monoclonal antibody regimen compared with methotrexate for the prevention of acute graft-versus-host disease after haploidentical hematopoietic stem cell transplantation. Eligible patients with hematologic malignancies scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation will be randomly assigned in a 1:1 ratio to receive either methotrexate-based prophylaxis or anti-CD25 monoclonal antibody-based prophylaxis, in combination with standard graft-versus-host disease prophylaxis including anti-thymocyte globulin, calcineurin inhibitor, and mycophenolate mofetil.
The primary objective is to compare 12-month graft-versus-host disease-free, relapse-free survival between the two groups. Secondary objectives include comparison of acute graft-versus-host disease, chronic graft-versus-host disease, oral mucositis, hematopoietic recovery, cytomegalovirus and Epstein-Barr virus reactivation, infection, relapse, non-relapse mortality, overall survival, and leukemia-free survival.
Patients with confirmed hematologic malignancies who are scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation.
Age 18 to 75 years.
Willing to provide written informed consent and accept random assignment.
Willing and able to comply with the study procedures throughout the study period.
Patients scheduled to undergo fully matched donor transplantation, unrelated donor transplantation, or umbilical cord blood transplantation.
Patients receiving grafts from maternal donors or collateral relative donors.
Patients with strongly positive donor-specific antibodies.
Patients whose transplantation regimen includes post-transplant cyclophosphamide for graft-versus-host disease prophylaxis.
Parallel
Methotrexate
DrugMethotrexate will be administered intravenously at 15 mg/m² on Day +1 and 10 mg/m² on Days +3, +6, and +11 after haploidentical hematopoietic stem cell transplantation for graft-versus-host disease prophylaxis.
Anti-CD25 Monoclonal Antibody
Biological/VaccineAnti-CD25 monoclonal antibody, also described as daclizumab in the protocol, will be administered intravenously at 1 mg/kg on Day 0 and Day +4 after haploidentical hematopoietic stem cell transplantation for graft-versus-host disease prophylaxis. The Day 0 dose will be administered 2 hours before stem cell infusion.
12-month graft-versus-host disease-free, relapse-free survival
Graft-versus-host disease-free, relapse-free survival is defined as survival without grade III-IV acute graft-versus-host disease, moderate or severe chronic graft-versus-host disease, disease relapse, or death from any cause, whichever occurs first.
Incidence of acute graft-versus-host disease
Proportion of participants who develop acute graft-versus-host disease after transplantation. Acute graft-versus-host disease will be assessed according to international criteria and MAGIC grading.
Incidence of grade II-IV acute graft-versus-host disease
Proportion of participants who develop grade II-IV acute graft-versus-host disease after transplantation.
Incidence of grade III-IV acute graft-versus-host disease
transplantation Proportion of participants who develop grade III-IV acute graft-versus-host disease after transplantation.
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