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临床试验/NCT06030089
NCT06030089已完成不适用

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

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月26日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Newly diagnosed AML patients

干预措施: Pharmacokinetic sampling (Other)

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax

Experimental

Newly diagnosed AML patients

干预措施: Vital status determination (Other)

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax

Experimental

Newly diagnosed AML patients

干预措施: Toxicity assessments (Other)

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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