NCT07672262RecruitingPhase 2
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 · Last updated 6 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- First submitted
- 19 Jun 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jun 2030
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07672262
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 226
- From 1 Jun 2026 to the primary completion date, 1 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically active cardiovascular disease (uncontrolled arrhythmia/hypertension, NYHA Class 3/4 heart failure, myocardial infarction within 3 months)
- Other serious diseases limiting participation (e.g., severe infection, renal failure)
- Known HIV infection or uncontrolled severe viral hepatitis
- Any other conditions deemed unsuitable by the investigator
Other
- Active central nervous system (CNS) leukemia or extramedullary infiltration
- Pregnant or breastfeeding women
- Inability to understand, comply with protocol, or sign informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.