Genetic factors affecting treatment response in acute myeloid leukemia
Official title: A Prospective Pilot Study of the Genetic Determinants of Toxicity and Response to Azacitidine and Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia Through Evaluation of Polymorphisms in Pharmacokinetic Genes and Venetoclax Levels
Run by Wake Forest University Health Sciences · NCT06580106 · Data updated 2026-11-12
This study is testing how certain genetic differences affect the side effects and success of a treatment for people newly diagnosed with acute myeloid leukemia who are receiving azacitidine and venetoclax.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | April 9, 2025 |
| Main results expected | July 2027 |
| Study ends | January 2030 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT06580106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with a confirmed diagnosis of AML who are starting treatment with azacitidine and venetoclax.
✕Probably not a fit
Patients who are not newly diagnosed with AML or those who are fit for intensive induction therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research investigates how specific genetic variations influence the side effects and treatment outcomes for patients with newly diagnosed acute myeloid leukemia (AML) receiving azacitidine and venetoclax. It is a prospective pilot study that will collect buccal swabs for genetic analysis and measure venetoclax levels during treatment. The study aims to identify associations between genetic markers and the toxicity or efficacy of the treatment regimen. Participants will be recruited from designated cancer centers in North Carolina.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that minimize side effects and improve outcomes for AML patients.
How similar studies have gone: While this study explores genetic determinants in AML treatment, similar approaches in pharmacogenomics have shown promise in other cancer treatments, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * None
Where it's running
-
Levine Cancer Institute
Charlotte, North Carolina, United States Recruiting -
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Brittany Ragon, MD — Atrium Health Wake Forest Baptist Comprehensive Cancer Center
- Study coordinator: Courtney Schepel
- Email: courtney.schepel@advocatehealth.org
- Phone: (980) 292-0817
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.