Venetoclax + Azacitidine for Acute Myeloid Leukemia
(Viale-a Trial)

Recruiting in Palo Alto (17 mi)

+252 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own. This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are \>= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants. In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine. Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.

Eligibility Criteria

This trial is for adults diagnosed with Acute Myeloid Leukemia (AML) who haven't been treated before and can't have standard chemotherapy due to age or health issues. They must be expected to live at least 12 weeks, able to consent, and if of childbearing potential, agree to use birth control.

Inclusion Criteria

I am over 18 and can care for myself, but my ability to do daily activities may vary with my age.

My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

I am a woman who can have children and my pregnancy test is negative.

+8 more

Exclusion Criteria

I am currently being treated for a serious infection.

Participant is currently participating in another research or observational study.

I have had CAR-T cell therapy or experimental treatments for my blood cancer.

+9 more

Participant Groups

The study tests whether Venetoclax combined with Azacitidine is more effective than Azacitidine alone in treating AML. It's a Phase 3 trial where two-thirds of the patients will receive both drugs while one-third will get a placebo with Azacitidine.

3Treatment groups

Active Control

Placebo Group

Group I: Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2Active Control2 Interventions

Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).

Group II: Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2Active Control2 Interventions

Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).

Group III: Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2Placebo Group2 Interventions

Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, every day (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).

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

🇪🇺 Approved in European Union as Vidaza for: