Anti-CD25 Monoclonal Antibody for Prevention of Acute GVHD After Haploidentical HSCT
Recruiting
Phase 3
Interventional Study
Graft Versus Host Disease
Hematologic Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 186 (estimated)
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Other
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About This Trial
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-contr…
Trial Locations
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Eligibility Criteria
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 w…
Contacts