Clinical trial · Interventional
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
NCT03256071CI-TRIAL-00029180unknownPhase 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)
The purpose of this prospective, open-label, randomized multicenter study is to evaluate the safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Conditioning | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine plus Modified BUCY | Drug | — | UNRESOLVED |
| Modified BUCY | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Decitabine plus Modified BUCY
- description
- For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Decitabine plus Modified BuCy regimen consisted of decitabine,semustine,cytarabine, busulfan and cyclophosphamide.
- interventionNames
- Drug: Decitabine plus Modified BUCY
- type
- ACTIVE_COMPARATOR
- label
- Modified BUCY
- description
- For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Modified BuCy regimen consisted of semustine,cytarabine, busulfan and cyclophosphamide.
- interventionNames
- Drug: Modified BUCY
Primary outcomes (2)
- measure
- disease-free survival (DFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria:
* Age 12 to 60 years.
* Diagnosis of high-risk acute myeloid leukemia at the time of transplant. ("High-risk" AML features are defined by the following: relapsed or primary refractory AML; Secondary AML（AML Secondary to myelodysplastic syndrome(MDS) or treatment-related AML); extramedullary leukemia; adverse cytogenetic abnormalities of monosomy 5, monosomy 7, or deletion of 5q; or presence of FLT3 positive internal tandem duplication (FLT3/ITD+), particularly high allelic ratio.)
* Patient must have adequate pre-transplant organ function.
Exclusion Criteria:
* Age \<12 or \>60 years.
* Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen.
* Any other severe concurrent diseases, or have a history of serious organ dysfunction.
* Pregnant or lactating females.References
Publications (0)
Data not yet available
No reference posted for this study.