Venetoclax + Azacitidine for Leukemia
(VIALE-M Trial)
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Confirmation
Participants receive venetoclax once daily (QD) for up to 24 cycles and azacitidine (AZA) QD on Days 1-5 of each 28-day cycle for up to 6 cycles to determine the recommended Phase 3 dose (RPTD)
Dose Finding
Participants receive venetoclax QD and AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine the recommended Phase 3 dose (RPTD)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Venetoclax
Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Roche-Genentech
Industry Sponsor