Azacitidine With or Without Venetoclax to Keep Acute Myeloid Leukemia in Remission
Compares azacitidine alone or with venetoclax after remission in acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 75 years old?
Source: NCT07539818, who can take part
Where in China
- Blood Diseases HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT07539818
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia
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.
Inclusion: 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.
Exclusion: Prior allogeneic hematopoietic stem cell transplantation; 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.