Clinical trial · Interventional
VA Consolidation in Intermediate-Risk AML
A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Intermediate-Risk Acute Myeloid Leukemia
- 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)
This clinical trial aims to compare the efficacy and safety of venetoclax-based consolidation therapy versus conventional consolidation chemotherapy (intermediate/high-dose cytarabine) in newly diagnosed adult patients with intermediate-risk acute myeloid leukemia (AML). Participants must have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned to undergo 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 |
| Consolidation Therapy | — | UNRESOLVED | — |
| Intermediate Risk Acute Myeloid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine ± Anthracycline | Drug | — | UNRESOLVED |
| Venetoclax and Azacitidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Venetoclax + Azacitidine Consolidation
- description
- Venetoclax: 400 mg, orally, once daily on Days 1-28. (Dose adjustment required per prescribing information/guidelines when combined with CYP3A4 inhibitors). Azacitidine: 75 mg/m²/day, subcutaneously or intravenously, on Days 1-7. Patients will receive 1-2 cycles of this regimen before proceeding to allo-HSCT.
- interventionNames
- Drug: Venetoclax and Azacitidine
- type
- ACTIVE_COMPARATOR
- label
- Conventional Consolidation Chemotherapy
- description
- Cytarabine (AraC): ≥6g/m² per cycle (e.g., 1-2g/m², every 12 hours on days 1-3), administered intravenously. May be combined with anthracycline/anthraquinone agents per standard practice. Patients will receive 1-2 cycles of this regimen before proceeding to allo-HSCT.
- interventionNames
- Drug: Cytarabine ± Anthracycline
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO 2022 classification criteria; * Age ≥ 18 years; * Classified as intermediate-risk based on European LeukemiaNet (ELN) 2022 prognostic risk stratification; * Achieved first complete remission (CR) or CR with incomplete hematologic recovery (CRi) after ≤ 2 cycles of Venetoclax + Azacitidine (VA) induction therapy; * Has a suitable donor and is planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT); * ECOG performance status score 0 to 2 * Adequate organ function: creatinine clearance ≥ 50 mL/min; AST and ALT ≤ 3 × ULN; total bilirubin ≤ 2 × ULN; LVEF ≥ 50%; life expectancy \> 8 weeks * Voluntarily signed informed consent form and able to comply with study requirements Exclusion Criteria: * Clinically active cardiovascular disease (uncontrolled arrhythmia/hypertension, NYHA Class 3/4 heart failure, myocardial infarction within 3 months) * Active central nervous system (CNS) leukemia or extramedullary infiltration * Other serious diseases limiting participation (e.g., severe infection, renal failure) * Known HIV infection or uncontrolled severe viral hepatitis * Pregnant or breastfeeding women * Inability to understand, comply with protocol, or sign informed consent * Any other conditions deemed unsuitable by the investigator
References
Publications (0)
Data not yet available