Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
NCT ID: NCT06580106
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-04-09
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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AML participants who are receiving or are planned to receive azacitidine plus venetoclax
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.
Biospecimen samples
Buccal swabs and Blood samples will be collected throughout study.
Interventions
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Biospecimen samples
Buccal swabs and Blood samples will be collected throughout study.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Atrium Health Levine Cancer Institute
OTHER
Swim Across America
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Brittany Ragon, MD
Role: PRINCIPAL_INVESTIGATOR
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Locations
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Levine Cancer Institute
Charlotte, North Carolina, United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LCI-LEU-AML-VENTOX-001
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00116209
Identifier Type: -
Identifier Source: org_study_id
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