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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
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

Study 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.Check my eligibility
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.See study design
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.
Select...
I do not have symptoms of brain or spinal cord disease.
Select...
My leukemia is confirmed as non-APL and AML according to WHO standards.
Select...
I am between 18 and 59 years old.
Select...
My liver functions are within normal limits, unless affected by leukemia.
Select...
My leukemia is considered high-risk according to European standards.
Select...
My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
I have not received any treatment for AML.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response Rate, measured by the European Leukemia Net definition: (CRMRD-+CR+CRi+MLFS)
Secondary outcome measures
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%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
SARS-CoV-2 test positive
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

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
~1990
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,342 Total Patients Enrolled
AbbVieIndustry Sponsor
950 Previous Clinical Trials
496,892 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

Frequently Asked Questions

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

Are there any unfilled positions for volunteers in this experiment?

"After checking clinicaltrials.gov, it appears that this trial is still looking for participants. The listing was first uploaded on November 14th, 2018 and the last update was on August 22nd, 2022."

Answered by AI

Does Venetoclax carry any serious side effects?

"Even though there is no data demonstrating efficacy, Venetoclax received a safety score of 2 because Phase 2 trials offer evidence that it is not harmful."

Answered by AI

Does this research involve middle-aged or elderly patients?

"This clinical study includes an age range of 18 to 59 years old, as denoted by the inclusion criteria."

Answered by AI

Is there a precedent for using Venetoclax in this way?

"350 clinical trials are being conducted worldwide for Venetoclax. Of these, 55 have progressed to Phase 3. Many of the trials originate from Toronto, but there are 11288 locations running active trials."

Answered by AI

To what purpose is Venetoclax most often employed?

"Venetoclax has a wide range of potential applications including induction chemotherapy, treatment of refractory anemias, and management of leukemia."

Answered by AI

How many subjects are being admitted into this research project?

"The information available on clinicaltrials.gov verifies that this study is actively recruiting patients. The listing was first created on November 14th, 2018 and updated as recently as August 22nd, 2020. Currently, 36 individuals are needed to fill the slots at a single site location."

Answered by AI

Could I join this clinical trial?

"This leukemia study has 36 slots available for patients aged 18-59."

Answered by AI
~1 spots leftby Jun 2024