NCT07539818RecruitingPhase 3
Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML
A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This is a prospective, multicenter, randomized, open-label, phase III trial evaluating the efficacy and safety of azacitidine plus venetoclax versus azacitidine alone as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation. Eligible patients aged 14 to 74 years are randomized 1:1 to receive either azacitidine 50 mg/m²/day on days 1-5 every 6 weeks for up to 12 cycles, or the same azacitidine regimen combined with venetoclax 400 mg on days 1-7 per cycle. The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of relapse (CIR), minimal residual disease (MRD) conversion rate, and safety. A total of 788 patients are planned with stratification by prior venetoclax exposure and MRD status.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 788 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 15 May 2026
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07539818
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 788
- From 15 May 2026 to the primary completion date, 1 Apr 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.
Prior treatment
- Prior allogeneic hematopoietic stem cell transplantation
Other
- Acute promyelocytic leukemia with PML-RARA
- AML with BCR-ABL
- Active central nervous system involvement
- Planned allogeneic HSCT within 6 months
- Deemed unsuitable by investigator
Who the study is looking for
- Diagnosis of AML per WHO 2022 or ICC criteria, or MDS/AML (10-20% blasts) per ICC
- Age ≥14 and \<75 years
- ECOG performance status 0-2
- First complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation
- Received at least 2 cycles of intermediate- or high-dose cytarabine (cumulative dose ≥6 g/m² per cycle)
- Time from first CR/CRi to enrollment ≤10 months, and time from last treatment to enrollment ≤3 months
- MRD-negative or low-level MRD detectable; MRD-positive patients are excluded
- Signed informed consent
Age in the registry: 14 years to 75 years · 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 |
|---|---|---|---|
| Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.