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DNA Methyltransferase Inhibitor

Venetoclax + Azacitidine for Acute Myeloid Leukemia (VIALE-T 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 meet adequate renal, hepatic and hematologic criteria as described in the protocol.
Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 45 days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 39 months after the first participant is randomized
Awards & highlights

VIALE-T Trial Summary

This trial is testing if a combination of venetoclax and azacitidine can improve RFS in AML patients compared to BSC following allogeneic stem cell transplantation.

Who is the study for?
This trial is for AML patients who are at least 18 years old for Part 1 and at least 12 for Part 2, have had or are planning an allogeneic stem cell transplant, and meet specific health criteria. It's not open to those with certain infections, a history of other cancers within the last two years (with some exceptions), or disease progression on venetoclax before.Check my eligibility
What is being tested?
The study tests if Venetoclax combined with Azacitidine improves survival in AML patients after stem cell transplantation compared to just supportive care. The first part determines the best dose; the second part compares effectiveness and safety between the two approaches.See study design
What are the potential side effects?
Venetoclax and Azacitidine can cause side effects like low blood counts leading to bleeding or infection risks, fatigue, nausea, diarrhea, liver problems, and potential allergic reactions.

VIALE-T Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney, liver, and blood tests meet the study's requirements.
Select...
I have AML and am planning or have had a stem cell transplant within 45 days.
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I am over 17 with a KPS score above 50, or 12-16 years old with a Lansky score above 40.
Select...
I am at least 18 years old for Part 1 or at least 12 years old for Part 2.

VIALE-T Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 39 months after the first participant is randomized
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 39 months 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) Following Administration of Venetoclax and Azacitidine (Part 1)
Overall Survival (OS) (Part 2)
Secondary outcome measures
Change From Randomization in Fatigue in Adult Participants (Part 2)
Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2)
Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L)
+6 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

VIALE-T Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2: Arm B - Best Supportive Care (BSC)Experimental Treatment1 Intervention
Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)
Group II: Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSCExperimental Treatment3 Interventions
Participants will be administered with venetoclax and AZA at a dose level determined in Part 1 in addition to best supportive care (when required). Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days).
Group III: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive CareExperimental Treatment3 Interventions
Participants will be administered various doses and dose regiments of venetoclax and AZA. Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
946 Previous Clinical Trials
496,007 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
140,688 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04161885 — Phase 3
Acute Myeloid Leukemia Research Study Groups: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care, Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC, Part 2: Arm B - Best Supportive Care (BSC)
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04161885 — Phase 3
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04161885 — Phase 3

Frequently Asked Questions

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

Are there any available slots for participants in this clinical trial?

"According to the latest information on clinicaltrials.gov, this trial is still recruiting patients. The first posting was on February 26th, 2020 and the page was last updated on October 31st, 2020."

Answered by AI

What are the most popular medical applications for Venetoclax?

"Venetoclax is often used to treat induction chemotherapy, as well as other blood disorders such as refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."

Answered by AI

Could you please tell us what the side effects of Venetoclax are?

"Venetoclax has received a safety score of 3. This is because it has reached Phase 3 in clinical trials, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

What are the primary goals of this experiment?

"The primary objective for this clinical trial, which will follow participants for up to 39 months after enrolling the first person, is to assess the number of people who experience dose-limiting toxicities after receiving venetoclax and azacitidine. Additionally, the study will track secondary outcomes including GvHD-free and relapse-free survival rates, GvHD rate, and time to deterioration in global health status or quality of life."

Answered by AI

How many sites are participating in this clinical trial?

"This clinical trial has 60 enrollees at locations such as Montreal General Hospital - McGill University Health Center /ID# 215253 in Montreal, Weill Cornell Medical College /ID# 214887 in New york, and Saskatoon Cancer Centre /ID# 238821 in Saskatoon. There are also 60 other locations where patients are participating."

Answered by AI

What other Venetoclax studies have taken place?

"350 clinical trials worldwide are currently underway to study Venetoclax. Of those, 55 are Phase 3 trials. The majority of these trials are based in Edmonton, Alberta, but there are 11235 locations running studies for this treatment."

Answered by AI
~184 spots leftby Nov 2026