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Nucleoside Metabolic Inhibitor

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

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have adequate renal function as demonstrated by a creatinine >= 30 mL/min.

Participant must have confirmation of Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities.

Must not have

Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy.

Participant has received Chimeric Antigen Receptor (CAR)-T cell therapy or experimental therapies for MDS or AML.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 december 2021)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new combination treatment for acute myeloid leukemia (AML), a cancer of the blood and bone marrow. The treatment consists of the experimental drug venetoclax, which kills cancer cells by blocking a protein that allows them to stay alive, combined with azacitidine. The study will enroll approximately 400 participants globally and will compare the efficacy of the new combination treatment to azacitidine alone.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Venetoclax may cause side effects like low white blood cell count increasing infection risk, diarrhea, nausea, fatigue, and possibly liver problems. Azacitidine can also cause blood disorders, stomach issues, pain at injection site and fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have AML, untreated, and can't have standard treatment due to my age or health issues.

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I am 18 years old or older.

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I am over 75 or have certain health issues that make me ineligible for initial cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for a serious infection.

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

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I have acute promyelocytic leukemia or active AML in my brain or spinal cord.

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I am HIV positive or have hepatitis B or C.

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I have been treated for MDS or AML with specific medications.

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I have a history of blood disorders or specific genetic changes.

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I cannot take medicine by mouth due to a digestive issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the study start up to death (up to approximately 4.8 years; data cut-off date: 1 december 2021)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the study start up to death (up to approximately 4.8 years; data cut-off date: 1 december 2021)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the study start up to death (up to approximately 4.8 years; data cut-off date: 1 december 2021) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)

Secondary study objectives

Complete Remission (CR) Rate

Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh)

Event-free Survival (EFS)

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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).

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