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Randomized, Double-Blind, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

Clinical Trial Details

The purpose of this study is to determine what dose of the oral drug venetoclax in combination with azacitidine (AZA, subcutaneous or intravenous administration) is safe and effective as maintenance therapy in patients with acute myeloid leukemia (AML) in first remission after conventional induction and consolidation chemotherapy.

This study will also determine the dose of venetoclax in combination with CC-486 (orally administered Azacitidine, ‘Oral AZA’) that can be safely administered as maintenance therapy in participants with AML in first remission after conventional induction and consolidation chemotherapy. Other purposes of this study include evaluating the safety and efficacy of venetoclax in combination with CC-486 (Oral AZA) when compared to placebo + CC-486 (Oral AZA).

The study drugs have been approved by several regulatory authorities to treat specific medical conditions, including AML, in patients separately but they are not approved to treat AML in patients in first remission following induction + consolidation chemotherapies when given in these combinations. Therefore, the use of the combination of study drugs is considered investigational (experimental) for the purposes of this study, meaning they are not approved by the U.S. Food and Drug Administration (FDA).

CC-486 is approved by the FDA for continued treatment of patients with acute myeloid leukemia who are in first remission. Venetoclax 400mg is the FDA approved dose used in combination with Azacitidine in newly diagnosed AML patients who are ineligible for intensive chemotherapy.

There is data to support that venetoclax + AZA combination can eliminate leukemia cells in patients with AML and that a venetoclax + AZA combination can be dosed safely and induces responses in AML patients.

This study consists of two parts. Depending on which part of the study participants are enrolled in, they will receive either venetoclax and azacitidine, venetoclax and CC-486, or CC-486 and placebo. The study doctor will inform participants on what part of the study they will be participating in. 

Study participation may last up to 5 years. Participants may receive study treatment for up to 2 years or longer if the study doctor determines treatment is in the best interest of the participant. Study treatment may end if the disease worsens, treatment is no longer tolerated, or participants meet the criteria for early discontinuation from the study.

Key Eligibility: 
  1. Over the age of 18
  2. Diagnosed with AML
  3. In first remission after conventional induction and consolidation chemotherapy

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan


Tania J. Curcio, NP, FNP-BC
(212) 746-2571

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:





Age Group