Observational Study of Azacitidine and Venetoclax in AML

This study is looking at how your genes might affect the side effects and results you experience when treated with azacitidine and venetoclax for Acute Myeloid Leukemia (AML). Researchers want to understand if certain genetic differences are linked to how well these medications work and what side effects you might have. You can join if you are 18 or older, have AML, and are planning to start treatment with azacitidine and venetoclax. The main goal is to track any side effects you experience from the start of venetoclax treatment through 30 days after your last dose. This is an observational study, meaning researchers will collect information from your standard care, not test a new drug. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This is an observational study planning to enroll 50 participants. It is not testing a new treatment but rather observing how patients respond to standard care.
What's involved
You would provide buccal (cheek) swabs and blood samples. These samples will be collected at various times during your treatment.
Compensation
Not stated in the trial record.
Follow-up
Your side effects will be tracked from the start of venetoclax treatment through 30 days after your last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06580106

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

Recruiting
Not specifiedAges 18+Observational
Wake Forest University Health Sciences
~50 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Biospecimen samples

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Toxicity side effect
Measured over From initiation of venetoclax through 30 days after last dose
Leukemia, Myeloid, Acute
2 sites across 1 states
North Carolina2
  • Brittany Ragon, MD · PRINCIPAL_INVESTIGATOR · Atrium Health Wake Forest Baptist Comprehensive Cancer Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed consent and HIPAA authorization for release of personal health information.
Age ≥ 18 years of age at the time of consent
Confirmed diagnosis of AML
Planned initial treatment with azacitidine and venetoclax
Ability to read and understand the English and/or Spanish language
As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study

Exclusion

None
  • Toxicity side effectFrom initiation of venetoclax through 30 days after last dose

    Defined as a binary variable indicating whether a participant experienced a Grade 3 or higher of specific side effects (including infections, anemia, thrombocytopenia, febrile neutropenia, neutropenia, nausea, diarrhea)