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DNA Methyltransferase Inhibitor

Venetoclax + Azacitidine for Leukemia

Phase 2
Recruiting
Led By Daniel Pollyea, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤2
Without clinical signs of active central nervous system disease
Must not have
Subject has a malabsorption syndrome or other condition that precludes enteral route of administration
Subject exhibits evidence of uncontrolled systemic infection requiring therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study start date to study end date, or death, whichever comes first, up to 4 years
Awards & highlights

Summary

This trial will test a new treatment for people with leukemia who have not responded to other treatments.

Who is the study for?
Adults aged 18-59 with newly diagnosed acute myeloid leukemia (AML) who haven't been treated before can join. They should be in relatively good health, with an ECOG score of ≤2, and have normal liver and kidney function. Men must use contraception; women not post-menopausal or without a hysterectomy/oophorectomy must use two forms of birth control or abstain from sex.
What is being tested?
The trial is testing the combination of two drugs, Venetoclax and Azacitidine, as a treatment for AML in non-elderly adults. It's aimed at those who are newly diagnosed and have not received any prior treatments for their condition.
What are the potential side effects?
Possible side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, fatigue, liver issues, kidney problems and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I do not have symptoms of brain or spinal cord disease.
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My leukemia is confirmed as non-APL and AML according to WHO standards.
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I am between 18 and 59 years old.
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My liver functions are within normal limits, unless affected by leukemia.
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My leukemia is considered high-risk according to European standards.
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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 not received any treatment for AML.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take medicine by mouth due to a digestive condition.
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I am currently being treated for a serious infection that is not under control.
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I am HIV positive.
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I am willing to undergo strong initial chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study start date to study end date, or death, whichever comes first, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and study start date to study end date, or death, whichever comes first, up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response Rate, measured by the European Leukemia Net definition: (CRMRD-+CR+CRi+MLFS)
Secondary study objectives
Incidence of Minimal Residual Disease (MRD) Negative Responses
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
One Year Event Free Survival
+2 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Sepsis
11%
SARS-CoV-2 test positive
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Azacitidine and VenetoclaxExperimental Treatment2 Interventions
Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2200
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor
1,004 Previous Clinical Trials
513,742 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,572 Total Patients Enrolled
Daniel Pollyea, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
111 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03573024 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Azacitidine and Venetoclax
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT03573024 — Phase 2
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03573024 — Phase 2
~8 spots leftby Jun 2026
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