Clinical Trial

TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in First Complete Remission

Study acronym: TBF-AML
Not Yet Recruiting
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Summary
Acute myeloid leukemia (AML) is a serious blood cancer that mainly affects older adults. For patients who achieve their first complete remission (CR1), allogeneic hematopoietic stem cell transplantation (HSCT) may provide a chance for long-term survival. However, relapse after transplantation remains a major challenge. This study aims to evaluate the effectiveness and safety of a conditioning regimen that combines thiotepa, busulfan, and fludarabine (TBF) before haploidentical peripheral blood stem cell transplantation (haplo-PBSCT) in elderly patients with AML in first complete remission. Eligible patients will receive the TBF conditioning regimen followed by stem cell transplantation from a partially matched donor. Participants will be followed to assess relapse-free survival, overall survival, transplant-related complications, and infections. The results of this study may help improve treatment strategies and outcomes for elderly AML patients undergoing transplantation.
Trial Details
NCT Number NCT07563920
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions Acute Myeloid Leukemia
Enrollment 93 participants
Start Date 2026-06
Primary Completion 2029-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-04