Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL): Analysis of Real-life Data: "Snapshot" at 3 Years From the End of Ibrutinib ATU. A National Study of the FILO-LLC Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Ibrutinib resistance
研究概览
简要总结
Assessment of the mutational profile of the residual clone and the distribution of lymphocyte subpopulations at 3 years of treatment with ibrutinib
This project has an epidemiological part: to establish the percentage of patients, in a real-life situation, still undergoing treatment 3 years after its initiation, as well as a biological part: to determine the evolution of the clone and the prevalence of BTK mutations and PLCg2 in the absence of clinical or biological criteria for scalability.
详细描述
Observationnal and biological study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients included in the ATU (epidemiology)
- •under treatment at 3 years of ibrutinib
- •more than 18 years old
排除标准
- •no ibrutinib treatment
结局指标
主要结局
Ibrutinib resistance
时间窗: under treatment at 3 years of ibrutinib
In the long term, this study will help to draft new recommendations from FILO-LLC concerning the detection of resistance and the management of patients.
次要结局
未报告次要终点