Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

Wake Forest University (WFU)

Status: Enrolling

Conditions: Leukemia, Myeloid, Acute

Treatments: Other: Biospecimen samples

Study type: Observational

Funder types: Other

Identifiers

NCT06580106

IRB00116209

LCI-LEU-AML-VENTOX-001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 can occur at any point before or after starting treatment during the study period. Venetoclax peak and trough levels will be obtained during SOC Aza/Ven treatments. Participants will be recruited initially at AHWFBCCC locations.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

AML participants who are receiving or are planned to receive azacitidine plus venetoclax

Description:

Buccal swabs for SNPs and pharmacogenomic analysis can occur at any point before or after starting treatment during the study period. 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.

Treatment:

Other: Biospecimen samples