Venetoclax + Azacitidine for Leukemia

(VIALE-M Trial)

Not currently recruiting at 372 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Acute promyelocytic leukemia, CNS involvement

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the combination of two drugs, venetoclax and azacitidine (a chemotherapy drug), to determine the optimal dose for treating acute myeloid leukemia (AML). It seeks to confirm and explore the safest and most effective dose to help achieve remission, where cancer is under control. The trial is open to individuals with newly diagnosed AML who have recently completed specific chemotherapy treatments. Participants should not have a history of certain types of leukemia or brain involvement of cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of venetoclax and azacitidine is generally well-tolerated by patients with acute myeloid leukemia (AML). Studies have found this treatment to be safe and effective, particularly in older patients. In some studies, about 67% of patients responded positively, experiencing beneficial effects.

However, there are some risks. One study found that less than 4% of patients on venetoclax experienced serious infections. This risk is relatively low compared to many cancer treatments, but it is important to be aware of it.

Overall, while some side effects are possible, previous studies have shown promise for this treatment. These findings suggest that the treatment is safe for most people considering joining a trial. Always consult a doctor to determine if it’s suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for leukemia, which often involve chemotherapy that targets rapidly dividing cells, the combination of venetoclax and azacitidine offers a more targeted approach. Venetoclax is unique because it specifically inhibits the BCL-2 protein, which helps cancer cells survive, thereby promoting their death. This mechanism can potentially make the treatment more effective in eliminating leukemia cells. Researchers are excited because this combination might not only enhance treatment efficacy but also reduce the side effects typically associated with traditional chemotherapy.

What evidence suggests that venetoclax and azacitidine could be effective for leukemia?

In this trial, participants will receive a combination of venetoclax and azacitidine, which studies have shown to be effective for treating acute myeloid leukemia (AML). Earlier research indicated that patients who received this combination experienced higher rates of complete remission, meaning their cancer symptoms greatly decreased or disappeared. The overall survival rate also improved compared to those who received a placebo. For older patients, this combination has shown promising results, even for those newly diagnosed or with difficult-to-treat cases. Although some side effects, such as pneumonia, have been reported, the treatment's benefits make it a strong option for managing leukemia. ^{1 6 7 8 9}

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

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.

Exclusion Criteria

My leukemia has affected my brain or spinal cord.

I have a history of acute promyelocytic leukemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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)

6 months

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)

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Azacitidine
• Venetoclax

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 3 (Dose Finding): Safety Expansion Experimental Treatment 2 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 Escalation Experimental Treatment 2 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 Confirmation Experimental Treatment 2 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 for the following indications:

Approved in European Union as Vidaza for:

• Acute myeloid leukemia
• Chronic myelomonocytic leukemia
• Myelodysplastic syndromes

Approved in United States as Vidaza for:

• Myelodysplastic syndromes
• Chronic myelomonocytic leukemia

Approved in Canada as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

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

Trials

27

Recruited

3,800+

Citations

1. nature.com nature.com/articles/s41375-025-02730-3

Outcomes of patients treated with venetoclax plus ... Efficacy, including composite complete remission and overall survival, were improved with venetoclax plus azacitidine vs. placebo plus ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12422247/

Efficacy of Venetoclax Combined with Azacitidine in Elderly ... Venetoclax combined with azacitidine has shown promising activity in newly diagnosed or relapsed/refractory AML, but real-world data on older ...

3. ashpublications.org ashpublications.org/blood/article/145/11/1126/534406/Efficacy-and-safety-of-venetoclax-plus-azacitidine

Efficacy and safety of venetoclax plus azacitidine for patients ... Overall, venetoclax plus azacitidine at the RP2D was well tolerated and had favorable outcomes. A phase 3 study (NCT04401748) is ongoing to ...

4. venclextahcp.com venclextahcp.com/aml/efficacy/ven-aza/survival-results.html

VEN+AZA: Overall survival (OS) data from the VIALE-A trial Fatal adverse reactions occurred in 23% of patients who received VENCLEXTA in combination with azacitidine, with the most frequent (≥2%) being pneumonia (4%), ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2012971

Azacitidine and Venetoclax in Previously Untreated Acute ... At a median follow-up of 14.9 months, the median overall survival was 16.9 months. This confirmatory trial (VIALE-A) was designed to evaluate ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02203773

NCT02203773 | Study of ABT-199 (GDC-0199) in ... This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (ABT-199) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6318429/

Venetoclax combined with decitabine or azacitidine in ... Venetoclax plus decitabine or azacitidine showed tolerable safety and favorable overall response rate (CR + CRi rate: 67%) in elderly patients with AML. This ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04161885

NCT04161885 | A Study Evaluating Safety and Efficacy of ... The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid ...

9. ashpublications.org ashpublications.org/bloodadvances/article/8/4/857/506893/Risk-of-infectious-adverse-events-of-venetoclax

Risk of infectious adverse events of venetoclax therapy for ... A large study pooling the safety data from 3 venetoclax CLL phase 1/2 trials found a lower prevalence of OIs of 3.1%, with a median time to OI ...