Anti-CD25 Monoclonal Antibody for Prevention of Acute GVHD After Haploidentical HSCT

NCT07689630 | Recruiting Phase 3

• 1 other identifier: UHCT260630
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Neoplasms; Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of acute graft-versus-host disease

  Up to 100 days after transplantation

• Incidence of grade II-IV acute graft-versus-host disease

  Up to 100 days after transplantation

• Incidence of grade III-IV acute graft-versus-host disease

  Up to 100 days after transplantation

Study Arms (2)

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.

Drug: Methotrexate

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.

Biological: Anti-CD25 Monoclonal Antibody

Interventions

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.

Methotrexate Group

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.

Anti-CD25 Monoclonal Antibody Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients undergoing a second transplantation.
• Patients who refuse to provide written informed consent.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease; Hematologic Neoplasms

Interventions

Methotrexate; PC61 monoclonal antibody

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Linghui Xia

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linghui Xia

CONTACT

+86 027-85726003; linghuixia@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)