Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasmatic dosage
研究概览
简要总结
The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Newly diagnosed AML patients
干预措施: Pharmacokinetic sampling (Other)
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Newly diagnosed AML patients
干预措施: Vital status determination (Other)
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Newly diagnosed AML patients
干预措施: Toxicity assessments (Other)
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Newly diagnosed AML patients
干预措施: Venetoclax and azacitidine combination (Drug)
结局指标
主要结局
Plasmatic dosage
时间窗: At 12 months after start of treatment or at relapse whichever comes first
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
次要结局
- Overall survival(1 year)
