RECRUITING

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-05

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06580106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* None

Inclusion Criteria

Exclusion 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

* None

Contacts and Locations

Study Contact

Courtney Schepel

CONTACT

(980) 292-0817

courtney.schepel@atriumhealth.org

Principal Investigator

Brittany Ragon, MD

PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Study Locations (Sites)

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Brittany Ragon, MD, PRINCIPAL_INVESTIGATOR, Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05

Study Completion Date2030-01

Study Record Updates

Study Start Date2025-05

Study Completion Date2030-01

Terms related to this study

Additional Relevant MeSH Terms

Leukemia, Myeloid, Acute