Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
Purpose
The purpose of this research is to see how certain genetic variations relate to side effects and outcomes experienced while receiving treatment with azacitidine and venetoclax.
Condition
- Leukemia, Myeloid, Acute
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Written informed consent and HIPAA authorization for release of personal health information. - Age ≥ 18 years of age at the time of enrollment - 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| AML participants who are receiving or are planned to receive azacitidine plus venetoclax | Buccal swabs for SNPs and pharmacogenomic analysis will be collected at baseline. Venetoclax peak and trough levels will be obtained during SOC Aza/Ven treatments. CYP3A activity will also be evaluated. Demographic and cancer related history will be acquired for each participant. During study participation, cancer treatment details including administration, dose modifications, delays, and reductions, including specific grade 3 toxicities, stem cell transplant status, symptom burden, disease response, and survival will be collected. Participants will be taken off study after three years. |
|
Recruiting Locations
Charlotte, North Carolina 28204
Winston-Salem, North Carolina 27157
More Details
- NCT ID
- NCT06580106
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
Detailed Description
This is a prospective pilot study of the association of SNPs and venetoclax levels with toxicity and response to azacitidine plus venetoclax (Aza/Ven) as well as pharmacogenomics and venetoclax levels in patients with newly diagnosed AML determined to be unfit for intensive induction. Newly diagnosed AML patients over 18 years old who receive Aza/Ven as standard of care will be eligible for this study. Buccal swabs for SNPs and pharmacogenomic analysis will be collected at baseline. Venetoclax peak and trough levels will be obtained during SOC Aza/Ven treatments. Participants will be recruited initially at AHWFBCCC locations.