Clinical trial · Interventional
TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in First Complete Remission
A Single-Center, Prospective, Single-Arm Clinical Study Evaluating the Efficacy and Safety of Thiotepa, Busulfan, and Fludarabine (TBF) Conditioning Regimen in Haploidentical Peripheral Blood Stem Cell Transplantation for Elderly Acute Myeloid Leukemia Patients in First Complete Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan (BU) | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Haploidentical Peripheral Blood Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arms Back to Arms and Interventions * Required * § Required if Study Start Date is on or after Janu
- description
- Participants will receive a conditioning regimen consisting of thiotepa, busulfan, and fludarabine (TBF) followed by haploidentical peripheral blood stem cell transplantation. Thiotepa is administered on day -7, busulfan on days -4 and -3, and fludarabine on days -6 to -2. Donor stem cells are infused on day 0. Standard graft-versus-host disease prophylaxis and supportive care will be provided according to institutional guidelines.
- interventionNames
- Drug: Thiotepa
- Drug: Busulfan (BU)
- Drug: Fludarabine
- Procedure: Haploidentical Peripheral Blood Stem Cell Transplantation
Primary outcomes (1)
- measure
- 1-year Relapse-Free Survival (RFS)
- timeFrame
- 12 months after transplantation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available