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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate Group | Active Comparator | 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. |
|
| Anti-CD25 Monoclonal Antibody Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 100 days after transplantation |
| Incidence of grade II-IV acute graft-versus-host disease |
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Inclusion Criteria：
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linghui Xia | Contact | +86 027-85726003 | linghuixia@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Linghui Xia | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| C584092 | PC61 monoclonal antibody |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Anti-CD25 Monoclonal Antibody | Biological | 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. |
|
Proportion of participants who develop grade II-IV acute graft-versus-host disease after transplantation. |
| Up to 100 days 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. | Up to 100 days after transplantation |
| D006425 |
| Hemic and Lymphatic Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |