Graft Versus Host Disease, Hematologic Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGMethotrexate
Methotrexate 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.
BIOLOGICALAnti-CD25 Monoclonal Antibody
Anti-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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
： 1. Patients with confirmed hematologic malignancies who are scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation. 2. Age 18 to 75 years. 3. Willing to provide written informed consent and accept random assignment. 4. Willing and able to comply with the study procedures throughout the study period.
Exclusion criteria
1. Patients scheduled to undergo fully matched donor transplantation, unrelated donor transplantation, or umbilical cord blood transplantation. 2. Patients receiving grafts from maternal donors or collateral relative donors. 3. Patients with strongly positive donor-specific antibodies. 4. Patients whose transplantation regimen includes post-transplant cyclophosphamide for graft-versus-host disease prophylaxis. 5. Patients undergoing a second transplantation. 6. Patients who refuse to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month graft-versus-host disease-free, relapse-free survival | 12 months after transplantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute graft-versus-host disease | Up to 100 days after transplantation | 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 | Up to 100 days after transplantation | 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 | Up to 100 days after transplantation | transplantation Proportion of participants who develop grade III-IV acute graft-versus-host disease after transplantation. |
Countries
China
Contacts
CONTACTLinghui Xia
PRINCIPAL_INVESTIGATORLinghui Xia
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed