Study of Thiotepa, Busulfan, and Fludarabine Conditioning Before Haploidentical Stem Cell Transplant in Older Adults With High-Risk Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating a conditioning treatment regimen combining thiotepa, busulfan, and fludarabine before haploidentical hematopoietic stem cell transplantation haplo-HSCT in elderly patients aged 55 to 70 years with high-risk acute myeloid leukemia AML. This prospective, single-arm, multicenter clinical trial aims to assess the safety and effectiveness of this regimen, focusing on 1-year relapse-free survival as the primary outcome. Participants will receive thiotepa at 5 mgkgday on Days -10 and -9, busulfan at 3.2 mgkgday on Days -8 to -6, fludarabine at 30 mgmday on Days -6 to -2, and rabbit anti-thymocyte globulin rATG at 1.5-2.5 mgkgday on Days -5 to -2 as their conditioning regimen. On Day 0, hematopoietic stem cells will be infused. Graft-versus-host disease prevention will involve cyclosporine A, mycophenolate mofetil, and methotrexate. Throughout the study, participants will be closely monitored for relapse-free survival over one year. Evaluations will include survival rates, relapse rates, and non-relapse mortality, with attention to organ function and overall health status. The trial is expected to continue through April 2029, enrolling 56 eligible patients and assessing treatment safety and outcomes over this period.

Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia