drugset / Trial / NCT07563920

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

NCT07563920

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-06
Primary completion
2029-06
Completion
2030-06

Drugs

EvaluationDrugModalityDoseRoute
Background Busulfan Small molecule 3.2 mg/kg Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Thiotepa Other / unclassified 5 mg/kg Intravenous