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DNA Methyltransferase Inhibitor

Venetoclax + Azacitidine for Leukemia (VIALE-M 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

Diagnosis of newly diagnosed acute myeloid leukemia (AML).

Participant meets the following disease activity criteria: Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured from baseline to approximately 3.5 years after the first participant is randomized

Awards & highlights

VIALE-M Trial Summary

This trial will test if the drug venetoclax, when combined with other drugs, can help to improve survival rates for patients with blood cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Venetoclax may cause side effects like low white blood cell count increasing infection risk, fatigue, nausea, diarrhea, constipation, coughing. Azacitidine could lead to anemia causing tiredness or shortness of breath; bruising/bleeding due to low platelets; fever; rash.

VIALE-M Trial Eligibility Criteria

Inclusion Criteria

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

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I have been recently diagnosed with acute myeloid leukemia.

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My AML is in remission after intensive chemotherapy, as per WHO criteria.

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

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My AML is classified as intermediate or high risk.

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I can take care of myself and am up and about more than half of my waking hours.

VIALE-M Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from baseline to approximately 3.5 years after the first participant is randomized

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured from baseline to approximately 3.5 years after the first participant is randomized

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from baseline to approximately 3.5 years after the first participant is randomized for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1)

Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3 Dose Finding Portion)

Secondary outcome measures

Change From Baseline in Patient Reported Outcomes (PRO) Fatigue Score Based on Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a (Part 2)

Change From Baseline in Patient Reported Outcomes (PRO) Fatigue Score Based on Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a (Part 3 Randomization Portion)

Change From Baseline in Patient Reported Outcomes (PRO) in Items from EORTC QLQ-C30 between Arms A and B (Part 2)

+9 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

Neutrophil count decreased

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Pneumonia pseudomonal

11%

Hypokalaemia

11%

Dermatitis

11%

Rhinovirus infection

11%

Pneumonia

11%

Abdominal pain

11%

Anaemia

11%

Sepsis

11%

Gastroenteritis

11%

SARS-CoV-2 test positive

11%

Electrocardiogram QT prolonged

11%

Febrile neutropenia

11%

COVID-19

11%

Supraventricular tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

VIALE-M Trial Design

3Treatment groups

Experimental Treatment

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

Participants will receive venetoclax QD for up to 24 cycles, CC-486 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, CC-486 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 48 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Venetoclax

2019

Completed Phase 3

~1990

CC-486

2015

Completed Phase 2

~630

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,993 Total Patients Enrolled

Roche-GenentechIndustry Sponsor

24 Previous Clinical Trials

3,573 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,827 Total Patients Enrolled

Media Library

Acute Myeloid Leukemia Research Study Groups: Part 3 (Dose Finding): Dose Escalation, Part 1: Dose Confirmation, Part 3 (Dose Finding): Safety Expansion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the main reasons that Venetoclax is prescribed?

"Venetoclax is often used to treat patients that have undergone induction chemotherapy. Additionally, it is an effective medication for treating other blood disorders like leukemia, myelocytic, acute, multilineage dysplasia, and refractory anemias."

Answered by AI

What are some other areas of research in which Venetoclax has been used?

"Originally, Venetoclax was studied way back in 2006 at Chinese University of Hong Kong-Prince of Wales Hospital. As of now, there are a total of 218 completed studies. Additionally, there are presently 350 live studies, with many of these studies running out of Tucson, Arizona."

Answered by AI

What goals does this medical trial hope to achieve?

"The goal of this study is to see if the treatment combination of venetoclax and azacitidine is safe and effective for patients with blood cancer. The study will measure the time from treatment to relapse or death, up to approximately 3 years, as its primary outcome. Secondary outcomes include overall survival, the percentage of patients who achieve minimal residual disease, and time to deterioration in global health status/quality of life."

Answered by AI

What is the maximum dosage of Venetoclax that has been found to be safe for human consumption?

"Venetoclax scores a 3 on Power's safety scale. This is because it is in Phase 3 clinical trials, which suggests that there is both some evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

How many different places are participating in this study?

"Currently, there are 46 patients enrolled in this study. The University of Arizona Cancer Center - Tucson /ID# 249899 in Tucson, Atlantic Health System /ID# 239323 in Morristown, and Northwell Health - Monter Cancer Center /ID# 240109 in Lake Success,are a few of the participating locations."

Answered by AI

How many people have been given the opportunity to participate in this medical study?

"In order to carry out this clinical trial, 482 patients that meet the inclusion criteria must be recruited. The sponsor, AbbVie, is running the trial from various locations, such as University of Arizona Cancer Center - Tucson /ID# 249899 in Tucson, Arizona and Atlantic Health System /ID# 239323 in Morristown, New jersey."

Answered by AI

Recent research and studies

Current Opinion in HematologyJournal

Maintenance Therapy for Acute Myeloid Leukemia: Sustaining the Pursuit for Sustained Remission

Shallis, Rory M., and Nikolai A. Podoltsev. 2020. “Maintenance Therapy for Acute Myeloid Leukemia: Sustaining the Pursuit for Sustained Remission”. Current Opinion in Hematology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/moh.0000000000000637.

Future OncologyJournal

Design of the VIALE-M Phase III Trial of Venetoclax and Oral Azacitidine Maintenance Therapy in Acute Myeloid Leukemia

Ivanov, Vladimir, Su-Peng Yeh, Jiri Mayer, Lalit Saini, Ali Unal, Michael Boyiadzis, David M Hoffman, et al.. 2022. “Design of the VIALE-M Phase III Trial of Venetoclax and Oral Azacitidine Maintenance Therapy in Acute Myeloid Leukemia”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2022-0450.

Future OncologyJournal

Design of the VIALE-M Phase III Trial of Venetoclax and Oral Azacitidine Maintenance Therapy in Acute Myeloid Leukemia

clinicaltrials.govStudy

A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy