Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venetoclax, Azacitidine.
- Who it may be relevant to
- Registry conditions: AML. Basic parameters: 14 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia
Overview
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.
Interventions
- Drug Venetoclax
400 mg on days 1-7, every 6 weeks for 12 cycles - Drug Azacitidine
50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles
Primary outcome measures
- Disease-Free Survival [Time frame: up to 2 years]
Secondary outcome measures (8)
- Overall Survival (OS) [Time frame: up to 2 years]
- Relapse-Free Survival (RFS) [Time frame: up to 2 years]
- Complete Remission Duration (CRd) [Time frame: up to 1 year]
- DFS-MRD [Time frame: Up to 2 years]
- RFS-MRD [Time frame: Up to 2 years]
- Cumulative Incidence of Relapse (CIR) [Time frame: Up to 5 years]
- CIR-MRD [Time frame: up to 5 years]
- MRD Negativity Conversion Rate [Time frame: up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07539818 · IIT2026028