Anti-CD25 antibody to prevent acute GVHD after haploidentical stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized Phase 3 trial comparing an anti-CD25 monoclonal antibody regimen to methotrexate for preventing acute GVHD after haploidentical allogeneic transplantation in adults with hematologic cancers. Participants are randomly assigned to receive either the anti-CD25 therapy or methotrexate, alongside standard GVHD prophylaxis, in a parallel design and open-label format. Eligible patients are adults 18 to 75 with hematologic malignancies and a haploidentical donor, without other conflicting donor types or prior transplant. The study aims to determine if the anti-CD25 approach reduces GVHD while maintaining engraftment and safety. Key outcomes likely include GVHD-free survival, engraftment kinetics, infection rates, and treatment-related adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Linghui Xia — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Linghui Xia
• Email: linghuixia@hust.edu.cn
• Phone: +86 027-85726003

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.