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.
Age 55 to 75 years
Diagnosed with acute myeloid leukemia (AML) based on morphology, immunophenotyping, cytogenetics, or molecular testing
First complete remission (CR1) or complete remission with incomplete hematologic recovery (CRi)
Eligible for haploidentical hematopoietic stem cell transplantation
Secondary AML (including AML evolving from myelodysplastic syndrome or therapy-related AML)
Active, uncontrolled infection
Severe uncontrolled systemic disease (e.g., unstable cardiovascular disease, recent stroke, or severe organ dysfunction)
HIV infection
Single group
Thiotepa
DrugThiotepa is administered intravenously at a dose of 5 mg/kg on day -7 as part of the TBF conditioning regimen prior to haploidentical peripheral blood stem cell transplantation.
Busulfan (BU)
DrugBusulfan is administered intravenously at a dose of 3.2 mg/kg on days -4 and -3 as part of the TBF conditioning regimen.
Fludarabine
DrugFludarabine is administered intravenously at a dose of 30 mg/m² daily from day -6 to day -2 as part of the conditioning regimen.
Haploidentical Peripheral Blood Stem Cell Transplantation
Procedure/SurgeryHaploidentical peripheral blood stem cell transplantation is performed on day 0 following conditioning. Donor stem cells are infused, and standard graft-versus-host disease prophylaxis and supportive care are provided according to institutional protocols.
1-year Relapse-Free Survival (RFS)
Relapse-free survival (RFS) is defined as the time from transplantation to the first occurrence of disease relapse or death from any cause. Patients who are alive without relapse at the last follow-up will be censored.
Overall Survival (OS)
Overall survival is defined as the time from transplantation to death from any cause. Patients alive at last follow-up will be censored.
Incidence of Acute Graft-Versus-Host Disease (aGVHD)
The cumulative incidence of grade I-IV and grade III-IV acute graft-versus-host disease within 180 days after transplantation, assessed according to standard criteria.
Incidence of Chronic Graft-Versus-Host Disease (cGVHD)
The cumulative incidence of all-grade and moderate-to-severe chronic graft-versus-host disease, assessed according to NIH consensus criteria.
Non-Relapse Mortality (NRM)
Non-relapse mortality is defined as death without evidence of disease relapse. Relapse is treated as a competing event.
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