Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Frequency measurement of BCL2 gene mutations
研究概览
简要总结
The purpose of this study is to collect medical informations and samples from refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms.
详细描述
The purpose of this study is to collect medical informations and samples (blood, bone marrow and/or lymph node) from refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms (BCL2 mutations, over-expression of other members of the BCL2 protein family and energy metabolism changes).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age greater than or equal to 18 years old;
- •chronic lymphocytic leukemia diagnosis according to iwCLL criteria;
- •refractory and/or relapsed disease during or after venetoclax treatment;
- •tumor samples available.
- •Relapse might be progressive chronic lymphocytic leukemia or transformation into Richter syndrome.
- •Patients must be able to express their opposition to be enrolled in this study, if need be.
- •Patients must be affiliated at the French Social Security system
排除标准
- •Patients of their legal guardians refusing to participate
结局指标
主要结局
Frequency measurement of BCL2 gene mutations
时间窗: immediately after the chronic lymphocytic leukemia progression
Frequency measurement of BCL2 gene mutations in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy
次要结局
- Correlation of resistance mechanisms with clinical staging(immediately after the chronic lymphocytic leukemia progression)
- Differential expression of candidate transcripts and proteins(immediately after the chronic lymphocytic leukemia progression)
- Correlation of resistance mechanisms with genomic chronic lymphocytic leukemia features(immediately after the chronic lymphocytic leukemia progression)
- Progression Free Survival according to resistance mechanisms(immediately after the chronic lymphocytic leukemia progression)
- Frequency measurement of 1q amplification(immediately after the chronic lymphocytic leukemia progression)