Azacitidine plus venetoclax maintenance vs azacitidine alone in AML
Official title: A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT07539818 · Data updated 2026-11-12
This trial tests whether adding venetoclax to azacitidine maintenance helps people with AML stay disease-free after achieving first remission.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 14 Years to 75 Years |
| Sex | All |
| Enrollment | 788 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | May 15, 2026 |
| Main results expected | April 1, 2030 |
| Study ends | April 1, 2031 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07539818 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ages 14–74 with AML in first CR or CRi after standard therapy, MRD-negative or low MRD, and who have received sufficient prior cytarabine.
✕Probably not a fit
Patients with active CNS involvement, prior allogeneic transplantation planned soon, or high MRD may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this phase 3, multicenter study, adults and older adolescents with AML who are in first complete remission or CRi after induction and consolidation are randomized to receive azacitidine alone or azacitidine plus venetoclax as maintenance. Treatment is given in cycles every six weeks for up to 12 cycles, with venetoclax added on days 1–7 in the combination arm. The study aims to compare disease-free survival, with secondary goals including overall survival, relapse-free survival, relapse risk, MRD changes, and safety. About 788 participants will be stratified by prior venetoclax exposure and MRD status to balance groups.
Why it matters
Potential benefit: If successful, the combination could prolong remission and potentially improve survival for patients in AML who have achieved first remission.
How similar studies have gone: Prior studies in AML have shown activity of venetoclax-based maintenance in select populations, but this specific maintenance comparison is being tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Hui Wei, MD
- Email: weihui@ihcams.ac.cn
- Phone: 13132507161
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.