A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
CompletedPhase 3Results postedLast updated 8 April 2026
What this trial tests
Phase 3 trial testing Venetoclax in Acute Myeloid Leukemia (AML) in 112 participants. Completed in 20 February 2026.
18 and older, any sex, with Acute Myeloid Leukemia (AML). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1)Primary· Up to 28 days (Cycle 1)
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Neutropenia
Group
Value
95% CI
Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2
3
Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2
4
Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2
4
Leukopenia
Group
Value
95% CI
Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2
1
Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2
0
Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2
0
Thrombocytopenia
Group
Value
95% CI
Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2
1
Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2
0
Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2
0
Platelet count decreased
Group
Value
95% CI
Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2
1
Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2
0
Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2
0
Number of Participants With DLTs of Venetoclax in Combination With Oral AZA (Part 3 Dose Finding Portion)Primary· Up to 28 days (Cycle 1)
DLTs are hematologic toxicities consisting of any Grade ≥ 3 neutropenia or thrombocytopenia lasting more than 7 days and nonhematologic toxicities as described in the protocol and evaluated by the Investigator and the Sponsor. In addition, AEs that lead to omitting \> 20% of the scheduled dose within the cycle is considered as a DLT unless clearly related to underlying disease. Treatment delay due to toxicity lasting greater than 14 days since the last dose of Venetoclax is also considered a DLT.
Time frame: All-cause mortality and adverse event tables include events reported from the time of informed consent to the interim cutoff date of 05OCT2022. The median time on follow-up was 446, 687, 389 days for Part 1 VEN400_AZA20, VEN400_AZA36, VEN400_AZA50 and 67.5, 275 days for Part 3 Dose Level 1 (VEN400_CC200), Dose Level 2 (VEN400_CC300), respectively..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07425808 — FLT3-ITD Targeted Therapy in Fit AML Patients
· Phase 2, PHASE3
· not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel
· Phase 2
· not yet recruiting
NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological
· Phase 1, PHASE2
· not yet recruiting
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients
· Phase 1
· not yet recruiting
NCT07511062 — Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML
· Phase 1
· not yet recruiting
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NCT07458542 — Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 8 April 2026
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