Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06580106
Status
Recruiting
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Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen samples — OTHER
    Buccal swabs and Blood samples will be collected throughout study.

Study Details

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.

Key Dates

Start date
Apr 9, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jan 31, 2030

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Toxicity side effect [ Time Frame: From initiation of venetoclax through 30 days after last dose ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Levine Cancer InstituteCharlotteNorth Carolina28204
Courtney Schepel
[email protected]
(980) 292-0817
Brittany Ragon, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Timothy Pardee, MD
[email protected]
336-716-2466
Timothy Pardee, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlotte, NC

By research site
Levine Cancer Institute· Charlotte, NCWake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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