Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M) [M19-708]

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225047

Enrollment

Registered

2020-02-03

Start date

2020-01-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia AML

Interventions

investigational material(s) Generic name etc : ABT-199 INN of investigational material : Venetoclax Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of newly diagnosed AML. Subject meets the following disease activity criteria: confirmation of AML by the WHO criteria (2016) confirmation of CR or CRi following completion of intensive Induction and Consolidation chemotherapies (note: additional consolidation therapy on-study will be considered a protocol violation) subject should be within one of the following time windows: achieved first CR or CRi (after induction) within 120 days of the first dose of study drug(Cycle 1 Day 1), or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies until enrollment (Cycle 1 Day 1) AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria Eastern Cooperative Oncology Group (ECOG) performance status of <= 2. Subjects with adequate hematological, renal and liver function test values as described in the clinical trial protocol.

Exclusion criteria

Exclusion criteria: No history of APL. No history of active central nervous system involvement with AML.

Design outcomes

Primary

Measure	Time frame
Part 1 (Dose Confirmation) - The primary endpoint is DLTs of venetoclax in combination with AZA. Part 3 (Dose Finding) - The primary endpoint is DLTs of venetoclax in combination with oral AZA.	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Overall Survival (OS) Minimal Residual Disease (MRD) PRO	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactPatients and HCP Contact

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026