Phase 3
Completed N=112
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
Source: ClinicalTrials.gov NCT04102020 ↗Enrolled (actual)
112
Serious AEs
22.3%
Results posted
Aug 2025
Primary outcomePrimary: Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1) — 3; 4; 4; 1 Participants
◆ Published Evidence
Emerging
15citations · ~4 / year
Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia.
Summary
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.
Linked Publications (2)
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Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia.
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Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1) |
3; 4; 4; 1; 0; 0 | — |
| PRIMARY Number of Participants With DLTs of Venetoclax in Combination With Oral AZA (Part 3 Dose Finding Portion) |
1; 2; 1; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of newly diagnosed acute myeloid leukemia (AML).
- Participant meets the following disease activity criteria:
- Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
- Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
- AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
- Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Exclusion Criteria
- History of acute promyelocytic leukemia (APL).
- History of active central nervous system involvement with acute myeloid leukemia (AML).
Data sourced from ClinicalTrials.gov (NCT04102020) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.