Clinical trial · Interventional
G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for Secondary Acute Myeloid Leukemia Undergoing Allo-HSCT
G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With Secondary Acute Myeloid Leukemia Evolving From MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
NCT05449899CI-TRIAL-00059558unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Allo-HSCT is the most effective way to cure sAML patients. At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT are evaluated.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Conditioning | — | UNRESOLVED | — |
| Secondary Acute Myeloid Leukemia Evolving From MDS | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan (BU) | Drug | Busulfan | ALIAS |
| Cyclophosphamide (CY) | Drug | Cyclophosphamide | ALIAS |
| Decitabine (DAC) | Drug | Decitabine | ALIAS |
| Fludarabine (FLU) | Drug | Fludarabine | ALIAS |
| Granulocyte Colony-Stimulating Factor(G-CSF) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- G-CSF+DAC+BF
- description
- For patients with sAML undergoing allo-HSCT, Granulocyte Colony-Stimulating Factor (G-CSF)+Decitabine+BF conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -6 to -3, Fludarabine (FLU) 30mg/m2/ day on days -7 to -3.
- interventionNames
- Drug: Granulocyte Colony-Stimulating Factor(G-CSF)
- Drug: Decitabine (DAC)
- Drug: Busulfan (BU)
- Drug: Fludarabine (FLU)
- type
- ACTIVE_COMPARATOR
- label
- G-CSF+DAC+BUCY
- description
- For patients with sAML undergoing allo-HSCT, Granulocyte Colony -Stimulating Factor (G-CSF)+Decitabine+BUCY conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -7 to -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3, -2.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Had a diagnosis of sAML * Age 18 to 65 years old * ECOG performance status of 0-2 * HCT-CI of 0-2 * Were willing to undergo allo-HSCT Exclusion Criteria: * Therapy-related MDS * Previous allo-HSCT * Uncontrolled infections * Liver or renal dysfunction * Severe concomitant conditions not suitable for the trial
References
Publications (0)
Data not yet available
No reference posted for this study.