Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LCI-LEU-AML-VENTOX-001 | Other Identifier | Atrium Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
| Swim Across America | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen samples | Other | Buccal swabs and Blood samples will be collected throughout study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity side effect | 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) | From initiation of venetoclax through 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Modification | A binary variable indicating whether a participant experienced a dose modification, including delay or reduction | Approximately 6 months or until last dose of Venetoclax, whichever came first |
| Disease Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Schepel | Contact | (980) 292-0817 | courtney.schepel@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Brittany Ragon, MD | Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
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
| Up to 3 years |
| Venetoclax levels | Will be defined as the maximum concentration of Venetoclax and is measured at 6 months if the participant is still receiving venetoclax | Approx 6 months |
| Overall survival | 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 | Approx 3 years |
| Dose modification due to nausea or diarrhea | A binary variable indicating whether a participant experienced a dose modification, including delay or reduction due to nausea or diarrhea | Approximately 6 months or until last dose of Venetoclax, whichever came first |
| Metabolizer status checklist | A categorical variable indicating whether a participant is a high, normal or low metabolizer based on pharmacogenomics analysis of SNP data | Approximately 6 months or until last dose of Venetoclax, whichever came first |
| Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |