Clinical trial · Interventional
Anti-CD25 Monoclonal Antibody for Prevention of Acute GVHD After Haploidentical HSCT
A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial of Anti-CD25 Monoclonal Antibody Versus Methotrexate for the Prevention of Acute Graft-Versus-Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD25 Monoclonal Antibody | Biological | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Methotrexate Group
- description
- Participants in this arm will receive methotrexate-based graft-versus-host disease prophylaxis after haploidentical hematopoietic stem cell transplantation. Methotrexate will be administered intravenously at 15 mg/m² on Day +1 and 10 mg/m² on Days +3, +6, and +11 after transplantation. Participants will also receive standard graft-versus-host disease prophylaxis including anti-thymocyte globulin, calcineurin inhibitor, and mycophenolate mofetil.
- interventionNames
- Drug: Methotrexate
- type
- EXPERIMENTAL
- label
- Anti-CD25 Monoclonal Antibody Group
- description
- Participants in this arm will receive anti-CD25 monoclonal antibody-based graft-versus-host disease prophylaxis after haploidentical hematopoietic stem cell transplantation. Anti-CD25 monoclonal antibody will be administered intravenously at 1 mg/kg on Day 0 and Day +4 after transplantation. On Day 0, the drug will be administered 2 hours before stem cell infusion. Participants will also receive standard graft-versus-host disease prophylaxis including anti-thymocyte globulin, calcineurin inhibitor, and mycophenolate mofetil.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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