← Back to Search

DNA Methyltransferase Inhibitor

Venetoclax + Decitabine for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Olatoyosi Odenike, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
High risk AML, including any of the following: Relapsed or refractory disease; TP53 mutant AML; Adverse risk cytogenetics including any of the following: 3 or more abnormalities; deletions involving chromosomes 5, 7, or 17; abnormalities in chromosome 11 involving MLL; t(6;9); inv(3) or t(3;3); ECOG performance status 0-2; Age 18 years or older
Adequate organ function as defined by all of the following: Creatinine clearance ≥30 mL/min, determined by the Cockroft-Gault formula, or measured by a 24 hour urine collection; AST and ALT ≤3 x ULN and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome or of non-hepatic origin i.e. leukemic involvement); Patients must be at least 2 weeks from major surgery, radiation therapy, or participation in other investigational trials, and must have recovered from clinically significant toxicities related to these prior treatments; Patients must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the i initiation of any screening or study specific procedures; Female patients of childbearing potential must have negative results for a pregnancy test; Patients must be willing to use appropriate contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing an experimental drug to see if it is safe and effective when given to people with a specific type of leukemia.

Who is the study for?
Adults with acute myeloid leukemia (AML) can join this trial. Phase 1 is for those with high-risk AML, including relapsed or refractory disease and specific genetic changes. They must have good organ function and not be on certain treatments recently. Phase 2 is specifically for untreated AML patients with TP53 mutations. Pregnant women, HIV-positive individuals, and those with other significant health issues cannot participate.Check my eligibility
What is being tested?
The study tests the safety of Venetoclax combined with Decitabine in treating AML. Participants will receive both drugs to see how well they tolerate them and what effects they have on their leukemia.See study design
What are the potential side effects?
Venetoclax may cause side effects like low blood cell counts leading to increased infection risk, bleeding or bruising; fatigue; nausea; diarrhea; pneumonia among others. Decitabine's side effects include anemia, neutropenia (low white blood cell count), thrombocytopenia (low platelets), fever, cough, and shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have AML with a TP53 mutation and haven't been treated for it yet.
Select...
My AML is considered high risk.
Select...
My condition has returned or didn't respond to treatment.
Select...
My leukemia is TP53 mutant.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
My kidneys are functioning well enough, as shown by tests.
Select...
My cancer has specific genetic features considered high-risk.
Select...
I have AML with a TP53 mutation and haven't been treated for it yet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The rate of dose limiting toxicity (DLT)
Secondary outcome measures
Assessment of Overall Survival
Levels of toxicity with combination regimen

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Pneumonia pseudomonal
11%
Hypokalaemia
11%
Dermatitis
11%
Rhinovirus infection
11%
White blood cell count decreased
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%
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: TreatmentExperimental Treatment2 Interventions
Cycle 1 of Treatment will be Decitabine days 1-10 plus Venetoclax ramp up on days 1-3 followed by Venetoclax target dose on days 4-21 Cycle 2 of Treatment will be Decitabine days 1-10 plus Venetcolax target dose days 1-21 During maintenance Decitabine on days 1-5 plus Venetoclax days 1-21
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,824 Total Patients Enrolled
AbbVieIndustry Sponsor
954 Previous Clinical Trials
501,018 Total Patients Enrolled
Olatoyosi Odenike, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
68 Total Patients Enrolled

Media Library

Decitabine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03844815 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Treatment
Acute Myeloid Leukemia Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT03844815 — Phase 1
Decitabine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03844815 — Phase 1

Frequently Asked Questions

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

What are the potential adverse effects of Venetoclax for patients?

"The safety of Venetoclax was judged to be a 1 due to the Phase 1 nature of the trial, which means that there is scarce evidence for its efficacy and security."

Answered by AI

What is the current sample size of this therapeutic research?

"Affirmative. Information found on clinicaltrials.gov confirms that this investigation is currently accepting new participants; the trial was originally posted November 18th 2019, and last updated May 16th 2022. The study requires 26 individuals to be recruited from one medical site."

Answered by AI

Are there any documented precedents of research into Venetoclax?

"Presently, the existing body of work on Venetoclax spans 302 active trials with 42 in Phase 3. Several studies are being conducted in Edmonton, Alberta; however, this drug is currently under study at 8576 different sites worldwide."

Answered by AI

What applications has Venetoclax demonstrated efficacy in?

"Venetoclax is often prescribed to treat refractory anemia, as well as other ailments such as chronic lymphocytic leukemia (CLL), intermediate-1 and intermediate-2 levels of International Prognostic Scoring System (IPSS) risk."

Answered by AI

Are there any vacancies left to join this medical trial?

"As indicated on clinicaltrials.gov, this medical trial is still open to enrolment and has been since November 18th 2019. It was last revised on May 16th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia
2019. "Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03844815.
~0 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top