Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML

NCT07539818 · tracked via the Priya Life Science China tracker

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Phase

Phase 3

Started

2026-05-15

Last updated

2026-10-26

Condition(s) studied

AML

Investigational drug(s) / intervention(s)

Venetoclax →Azacitidine →

Venetoclax: 400 mg on days 1-7, every 6 weeks for 12 cycles

Azacitidine: 50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles

Study summary

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.

Eligibility

Sex

ALL

Min age

14 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * Acute promyelocytic leukemia with PML-RARA * AML with BCR-ABL * Active central nervous system involvement * Prior allogeneic hematopoietic stem cell transplantation * Planned allogeneic HSCT within 6 months * Deemed unsuitable by investigator

Primary outcome measure(s)

Disease-Free Survival — up to 2 years

Trial sites (1)

Facility	City	Region	Status
Blood Diseases Hospital	Tianjin	Tianjin Municipality	Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07539818 on ClinicalTrials.gov ↗ ← All trials in China