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]

JRCT ID: jRCT2080225047

Registered date:03/02/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia
• Date of first enrollment: 14/01/2020
• Target sample size: 36
• Countries of recruitment: Japan,Asia except Japan,North America,South America,Europe,Oceania
• Study type: Interventional

Intervention(s)

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 material : Venetoclax will be administered orally once daily starting on Day 1 of each 28-day cycle.

control material(s)
Generic name etc : Supportive care
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

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 Outcome

safety
efficacy
pharmacokinetics
Overall Survival (OS)
Minimal Residual Disease (MRD)
PRO

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

No history of APL.

No history of active central nervous system involvement with AML.

Related Information

• Primary Sponsor: AbbVie G.K.
• Source(s) of Monetary Support: AbbVie Inc.
• Secondary ID(s): NCT04102020,JapicCTI-205141