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临床试验/NCT03662724
NCT03662724招募中不适用

Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax: The Venetoclax Registry

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Overall response rate of Venetoclax treatment.

研究概览

简要总结

Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax

详细描述

The aim of this study is to document all patients with AML who are treated with the BCL2 inhibitor Venetoclax outside a clinical trial in all hospitals participating in this registry study in a standardised manner. Data is collected retrospectively and multi-centric. It is neither a therapy study nor is the therapy influenced by this study.

  1. Systematic and uniform collection and documentation of all patients treated with the BCL2 inhibitor Venetoclax.
  2. Collection and integrative analysis of clinical data of included patients.
  3. Mutation analysis of available patient samples and correlation with clinical parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • relapsed/refractory AML

排除标准

  • 未提供

结局指标

主要结局

Overall response rate of Venetoclax treatment.

时间窗: 4 months

Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission)

次要结局

  • Overall survival during Venetoclax treatment(5 years)
  • Event-free survival during Venetoclax treatment(5 years)
  • Relapse-free survival during Venetoclax treatment(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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