Prospective, Multicenter, Clinical-biological Cohort Study to Assess Pharmacokinetics and Pharmacodynamics (PK-PD) of Venetoclax (VEN) in Patients With Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Clinical Endpoint
研究概览
简要总结
This is a prospective, multicenter, clinical-biological cohort study. Its objective is to assess the pharmacokinetics-pharmacodynamics (PK-PD) of venetoclax (VEN) in patients with Acute Myeloid Leukemia (AML).
This study involves only minimal risks and constraints related to the collection of biological samples (blood samples for PK testing) and the collection of clinical data. Therapeutic management of patients participating in this study is not changed. A total of 100 patients will be included in the study over a 12-month period. A maximum of 21 additional samples are planned, with a maximum of 12 mL of blood per sampling day (4 mL at each sampling time) for PK dosing of venetoclax.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Male or female patient aged of at least 18 years on day of signing informed consent
- •Patient with histologically-confirmed diagnosis of Acute Myeloblactic Leukaemia according to classification ELN 2022 (European Leukemia Net 2022)
- •Patient who has to initiate treatment venetoclax-azacitidine as first line. Note : triple associations with targeted therapy are not authorized
- •Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.
- •Patient must be affiliated or benificiary of a social security system.
排除标准
- •Patient with acute promyelocytic leukemia (APL, AML3)
- •Patient with AML eligible to intensive chemotherapy
- •Patient previously treaed with venetoclax and/or azacitidine
- •Patient participating to another clinical trial with a medicinal product
- •Any condition that contraindicates blood sampling procedures required by the protocol
- •Any psychological, family, geographical, or social situation that, according to investigator's judgment, could potentially prevent the signing of an informed consent form and/or woulld likely interfere compliance with study procedures.
- •Patient under curatorship, guardianship or judicial protection
- •Pregnant or breast-feeding female patient.
研究组 & 干预措施
Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line
Blood samples
干预措施: Pharmacokinetic dosages of venetoclax (Other)
结局指标
主要结局
Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Clinical Endpoint
时间窗: From the first day of venetoclax administration up to day 28 (end of the first venetoclax cure)
Proportion of patients with a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) or partial remission (PR) or no remission
Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint
时间窗: From the first day of venetoclax administration to end of the treatment (days)
To assess PK exposure parameters : AUC (area under the curve) of venetoclax at steady state
次要结局
- To assess inter-individual and intra-individual variability in plasma exposure to venetoclax.(From the first day of ventoclax administration and nd through study completion, at least 24 months)
- To assess relationship between different PK markers of venetoclax and its clinical efficacy.(From the first day of venetoclax administration and through study completion, at least 24 months)
- To assess correlation between plasmatic exposition to venetoclax and occurrence of adverse events(From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration)