Clinical trial · Interventional
Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT
Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- 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)
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.
Conditions
Conditions (4)
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 |
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Conditioning | — | UNRESOLVED | — |
| Elderly | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan (BU) | Drug | Busulfan | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| Fludarabine(Flu) | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dec+Flu+Bu Conditioning Regimen
- description
- For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -9 to -7；Fludarabine(Flu) 30mg/m2/day on days -6 to -3；Busulfan (BU) 3.2 mg/kg/day on days -5 to -4).
- interventionNames
- Drug: Decitabine
- Drug: Busulfan (BU)
- Drug: Fludarabine(Flu)
Primary outcomes (1)
- measure
- overall survival (OS)
- timeFrame
- 2 year
Secondary outcomes (3)
- measure
- disease-free survival (DFS)
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * AML patients older than 60 years, younger than 80 years * In complete remission before transplantation * With HLA-matched sibling donors Exclusion Criteria: * Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
References
Publications (1)
- DERIVEDLiu Q, Hu Z, Xu N, Jiang Y, Fan Z, Huang F, Lin R, Jin H, Zeng Y, He H, Zhu P, Yu G, Shi P, Sun R, Xu X, Li Z, Zhang Y, Sun J, Wang Y, Xuan L. Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trial. Lancet Reg Health West Pac. 2025 Aug 12;61:101664. doi: 10.1016/j.lanwpc.2025.101664. eCollection 2025 Aug. PMID 40831735