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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Toxicity side effect
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Biospecimen samples (Other)
结局指标
主要结局
Toxicity side effect
时间窗: 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)
次要结局
- Dose Modification(Approximately 6 months or until last dose of Venetoclax, whichever came first)
- Overall survival(Approx 3 years)
- Disease Response(Up to 3 years)
- Venetoclax levels(Approx 6 months)
- Dose modification due to nausea or diarrhea(Approximately 6 months or until last dose of Venetoclax, whichever came first)
- Metabolizer status checklist(Approximately 6 months or until last dose of Venetoclax, whichever came first)