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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Neoplasms; Graft Versus Host Disease
• Intervention / Treatment: Drug: Methotrexate; Biological: Anti-CD25 Monoclonal Antibody

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Linghui Xia; Phone Number: +86 027-85726003; Email: linghuixia@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Linghui Xia; Phone Number: +86 027-85726003; Email: linghuixia@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methotrexate Group; 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.	Drug: Methotrexate; 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.
Experimental: Anti-CD25 Monoclonal Antibody Group; 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.	Biological: Anti-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Investigators: Principal Investigator: Linghui Xia, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Graft vs Host Disease; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pterins; Pteridines; Aminopterin; Methotrexate; PC61 monoclonal antibody
• Other Study ID Numbers: UHCT260630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No