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Trial Title:
Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
NCT ID:
NCT06580106
Condition:
Leukemia, Myeloid, Acute
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Biospecimen samples
Description:
Buccal swabs and Blood samples will be collected throughout study.
Arm group label:
AML participants who are receiving or are planned to receive azacitidine plus venetoclax
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.
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 will be collected at baseline. Venetoclax peak and
trough levels will be obtained during SOC Aza/Ven treatments. Participants will be
recruited initially at AHWFBCCC locations.
Criteria for eligibility:
Study pop:
Participants diagnosed with AML who are receiving or are planned to receive azacitidine
plus venetoclax will be identified in clinic and presented informed consent for this
study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion 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
Exclusion Criteria:
- None
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Contact:
Last name:
Courtney Schepel
Phone:
980-292-0817
Email:
courtney.schepel@atriumhealth.org
Investigator:
Last name:
Brittany Ragon, MD
Email:
Principal Investigator
Start date:
November 2024
Completion date:
January 2030
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
Atrium Health Levine Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Swim Across America
Agency class:
Other
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06580106
