TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in First Complete Remission
Starting soon · Not applicable
Conditions studied: Acute Myeloid Leukemia
In brief
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.
Key facts
- Study ID
- NCT07563920
- Run by
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- People needed
- 93
- Starts
- 2026-06-01
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-05-04
Who can join
Age: 55 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Availability of a suitable haploidentical donor
- ECOG performance status 0-2
- Adequate organ function:
- Left ventricular ejection fraction ≥50%
- Oxygen saturation >92% on room air
- Serum creatinine ≤1.5 × upper limit of normal (ULN)
- Total bilirubin ≤1.5 × ULN
- AST and ALT ≤2.0 × ULN
- DLCO ≥40% and FEV1 ≥50%
- Ability to understand and sign informed consent
You may not qualify if…
- 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
- Active hepatitis B or C requiring antiviral treatment
- Pregnant or breastfeeding women
- Known hypersensitivity to study drugs
Full record on ClinicalTrials.gov
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