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Anti-metabolites

Azacitidine/Decitabine + Venetoclax for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Brian A Jonas
Research Sponsored by Brian Jonas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of AML by World Health Organization (WHO) 2016 criteria (Arber 2016)
Treatment naïve and eligible for venetoclax plus HMA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before or has come back.

Who is the study for?
Adults diagnosed with acute myeloid leukemia (AML) who have not been treated for AML before or whose AML has returned. They must have previously failed treatment with hypomethylating agents for a related blood disorder and be able to take oral medication. Women of childbearing age must test negative for pregnancy and agree to use contraception, as should men with partners of childbearing potential.Check my eligibility
What is being tested?
The trial is testing the combination of chemotherapy drugs azacitidine or decitabine with venetoclax in patients with AML that's either new or has come back after previous treatments. The goal is to see how well these drugs work together in stopping cancer cell growth by killing them, halting division, or preventing spread.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk and bleeding problems, fatigue, liver issues indicated by abnormal tests results, kidney function changes requiring monitoring and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is AML, confirmed by the latest WHO criteria.
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I have not received any treatment and am eligible for venetoclax plus HMA therapy.
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My previous treatment with HMA for a blood disorder did not work.
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I can swallow and keep down pills.
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I have been treated with decitabine or azacitidine for a blood disorder before.
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I am 18 years old or older.
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I can take care of myself but might not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate
Secondary outcome measures
Duration of CR/CRi (DoR)
Event-free survival
Incidence of adverse events
+5 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Abdominal pain
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Hypokalaemia
11%
Neutrophil count decreased
11%
Pneumonia
11%
Sepsis
11%
Anaemia
11%
Blood creatinine increased
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Dermatitis
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: Treatment (azacitidine, decitabine, venetoclax)Experimental Treatment3 Interventions
Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7 (for patients with prior decitabine use), or decitabine IV on days 1-5 (for patients with prior azacitidine), and venetoclax PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1950
Azacitidine
2012
Completed Phase 3
~1410
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

Brian JonasLead Sponsor
4 Previous Clinical Trials
70 Total Patients Enrolled
AbbVieIndustry Sponsor
972 Previous Clinical Trials
506,105 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,719 Previous Clinical Trials
40,963,538 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04905810 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (azacitidine, decitabine, venetoclax)
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04905810 — Phase 2
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04905810 — Phase 2
~5 spots leftby May 2025
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