Leukemia, Myeloid, Acute
Conditions
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.
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 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. Participants will be recruited initially at AHWFBCCC locations.
Interventions
OTHERBiospecimen samples
Buccal swabs and Blood samples will be collected throughout study.
Sponsors
Wake Forest University Health Sciences
Atrium Health Levine Cancer Institute
Swim Across America
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity side effect | From initiation of venetoclax through 30 days after last dose | Defined as a binary variable indicating whether a participant experienced a Grade 3 or higher of specific side effects (including infections, anemia, thrombocytopenia, febrile neutropenia, neutropenia, nausea, diarrhea) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose Modification | Approximately 6 months or until last dose of Venetoclax, whichever came first | A binary variable indicating whether a participant experienced a dose modification, including delay or reduction |
| Disease Response | Up to 3 years | For participants diagnosed with AML, response will be defined as a binary variable indicating if they had a Complete Remission (CR), Complete Remission with partial hematologic recovery (CRh), Complete Remission with incomplete hematologic recovery (CRi), Morphologic Leukemia-free state (MLFS), or partial response (PR) to induction therapy using the European LeukemiaNet (ELN 2022) criteria. Otherwise they will be considered a non-responder |
| Venetoclax levels | Approx 6 months | Will be defined as the maximum concentration of Venetoclax and is measured at 6 months if the participant is still receiving venetoclax |
| Overall survival | Approx 3 years | Duration of time from date of enrollment to death. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive |
| Dose modification due to nausea or diarrhea | Approximately 6 months or until last dose of Venetoclax, whichever came first | A binary variable indicating whether a participant experienced a dose modification, including delay or reduction due to nausea or diarrhea |
| Metabolizer status checklist | Approximately 6 months or until last dose of Venetoclax, whichever came first | A categorical variable indicating whether a participant is a high, normal or low metabolizer based on pharmacogenomics analysis of SNP data |
Countries
United States
Contacts
CONTACTCourtney Schepel
PRINCIPAL_INVESTIGATORBrittany Ragon, MD
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Outcome results
None listed