Recruiting

Azacitidine & Venetoclax

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06580106

Conditions

Leukemia, Myeloid, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen samples

Study Details

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.

Conditions

Leukemia, Myeloid, Acute

Study ID

NCT06580106

Start date

Apr 9, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen samples

Buccal swabs and Blood samples will be collected throughout study.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Courtney Schepel

(980) 292-0817courtney.schepel@advocatehealth.org

Locations

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Courtney Schepel

(980) 292-0817courtney.schepel@advocatehealth.org

Principal Investigator:

Brittany Ragon, MD

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Timothy Pardee, MD

336-716-2466tspardee@wakehealth.edu

Principal Investigator:

Timothy Pardee, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-24.