Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen samples.
- Who it may be relevant to
- Registry conditions: Leukemia, Myeloid, Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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 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.
Interventions
- Other Biospecimen samples
Buccal swabs and Blood samples will be collected throughout study.
Primary outcome measures
- Toxicity side effect [Time frame: From initiation of venetoclax through 30 days after last dose]
Secondary outcome measures (6)
- Dose Modification [Time frame: Approximately 6 months or until last dose of Venetoclax, whichever came first]
- Disease Response [Time frame: Up to 3 years]
- Venetoclax levels [Time frame: Approx 6 months]
- Overall survival [Time frame: Approx 3 years]
- Dose modification due to nausea or diarrhea [Time frame: Approximately 6 months or until last dose of Venetoclax, whichever came first]
- Metabolizer status checklist [Time frame: Approximately 6 months or until last dose of Venetoclax, whichever came first]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- Levine Cancer Institute — Charlotte
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Identifiers
NCT: NCT06580106 · IRB00116209 · LCI-LEU-AML-VENTOX-001