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Recruiting NCT07689630

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

Phase III Interventional Graft Versus Host Disease Hematologic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methotrexate, Anti-CD25 Monoclonal Antibody.
Who it may be relevant to
Registry conditions: Graft Versus Host Disease, Hematologic Neoplasms. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • 12-month graft-versus-host disease-free, relapse-free survival [Time frame: 12 months after transplantation]
Secondary outcome measures (3)
  • Incidence of acute graft-versus-host disease [Time frame: Up to 100 days after transplantation]
  • Incidence of grade II-IV acute graft-versus-host disease [Time frame: Up to 100 days after transplantation]
  • Incidence of grade III-IV acute graft-versus-host disease [Time frame: Up to 100 days after transplantation]

Eligibility criteria

Inclusion Criteria：

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT07689630 · UHCT260630

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗