Clinical trial NCT06580106: Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leukemia, Myeloid, Acute
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
name: Swim Across America
First posted: 2024-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with AML who are receiving or are planned to receive azacitidine plus venetoclax will be identified in clinic and presented informed consent for this study.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Toxicity side effect
timeFrame: From initiation of venetoclax through 30 days after last dose
Secondary outcomes:
measure: Dose Modification
timeFrame: Approximately 6 months or until last dose of Venetoclax, whichever came first
measure: Disease Response
timeFrame: Up to 3 years
measure: Venetoclax levels
timeFrame: Approx 6 months
measure: Overall survival
timeFrame: Approx 3 years
measure: Dose modification due to nausea or diarrhea
timeFrame: Approximately 6 months or until last dose of Venetoclax, whichever came first
measure: Metabolizer status checklist
timeFrame: Approximately 6 months or until last dose of Venetoclax, whichever came first
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
name: Brittany Ragon, MD
role: PRINCIPAL_INVESTIGATOR
References: