Venetoclax + Azacitidine for Leukemia
(VIALE-M Trial)

Recruiting in Palo Alto (17 mi)

+311 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with Acute Myeloid Leukemia (AML) who are in first remission after chemotherapy can join. They should have had a complete response within 120 days of the study drug or within 75 days from their last chemo. Participants need to be physically stable, with acceptable blood, kidney, and liver function tests and not have acute promyelocytic leukemia or AML affecting the brain.

Inclusion Criteria

I have been recently diagnosed with acute myeloid leukemia.

I achieved complete remission within 120 days of starting the study drug or had my last intensive chemotherapy no more than 75 days ago.

My AML is classified as intermediate or high risk.

+3 more

Exclusion Criteria

My leukemia has affected my brain or spinal cord.

I have a history of acute promyelocytic leukemia.

Participant Groups

The trial is testing oral Venetoclax tablets combined with Azacitidine (AZA), compared to just AZA alone as maintenance therapy for AML patients in remission. The study has two parts: one to confirm the dose of Venetoclax with AZA, and another to find the right dose when combined with CC-486.

3Treatment groups

Experimental Treatment

Group I: Part 3 (Dose Finding): Safety ExpansionExperimental Treatment2 Interventions

Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.

Group II: Part 3 (Dose Finding): Dose EscalationExperimental Treatment2 Interventions

Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).

Group III: Part 1: Dose ConfirmationExperimental Treatment2 Interventions

Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.

Azacitidine is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Vidaza for: