Clinical Trial

Efficacy and Safety of UCBT With TMI -Based Conditioning Regimen for Adults With Refractory/Relapsed Aplastic Anemia

Study acronym: TMI
Not Yet Recruiting Phase 2
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Summary
Refractory/relapsed aplastic anemia (AA) in adults remains a clinical challenge that is frequently encountered and urgently needs to be resolved. Salvage treatment should prioritize hematopoietic stem cell transplantation (HSCT). Unrelated cord blood is an ideal source of hematopoietic stem cells due to its easy availability, low immunogenicity, and low incidence of chronic graft-versus-host disease (cGVHD) after transplantation.The optimization of the conditioning regimen for UCBT is a crucial factor in determining patient outcomes. This is a Phase II clinical study. A total of 11 adult patients with refractory/relapsed AA will be treated with a UCBT regimen based on a TMI-based conditioning regimen. Patients who meet the inclusion/exclusion criteria will sign an informed consent form before undergoing cord blood transplantation. The efficacy (12-month EFS) and safety of the regimen will be assessed 12 months after transplantation.
Trial Details
NCT Number NCT07078721
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Aplastic Anemia Idiopathic
Enrollment 11 participants
Start Date 2025-07-20
Primary Completion 2028-01 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2025-07-22