Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 38
- 主要终点
- Number of patients experiencing toxicities
研究概览
简要总结
The present study aims at obtaining more in-depth information on how patients with chronic lymphocytic leukemia treated with idelalisib and rituximab react to treatment.
详细描述
This cohort study will recruit patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab between 01/07/2014 and 31/05/2017 at European centres adhering to the GIMEMA group and the ERIC group.
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
- •Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/SLL) according to the World Health Organisation (WHO) classification
- •Treatment with idelalisib and rituximab started between the date of Country marketing authorization approval of idelalisib (EMA approval 18/09/2014) and 31/05/2017 given at European centres adhering to the GIMEMA group and the ERIC group.
- •One of the two following conditions must be satisfied:
- •Previously untreated CLL requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)] with deletion 17p13 and/or TP53 mutation.
- •Relapsed refractory CLL., i.e. patients who received at least one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, or high dose steroids requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)
- •Age ≥ 18 years.
- •Signed written informed consent, if applicable, according to ICH/EU/GCP and national local law.
排除标准
- •Patients with CLL treated with idelalisib within interventional clinical trials or outside the approved indication.
- •Patients with:
- •Transformation of CLL to aggressive lymphomas (Richter's Syndrome).
- •HIV infection.
- •Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
研究组 & 干预措施
Study group
All patients being observed during the study duration.
干预措施: idelalisib and rituximab (Drug)
结局指标
主要结局
Number of patients experiencing toxicities
时间窗: At 12 months from treatment start
Safety profile of idelalisib and rituximab
Number of patients responding to treatment
时间窗: At 12 months from treatment start
Efficacy profile of idelalisib and rituximab
次要结局
- Number of patients achieving response(At 12 months from treatment start)
- Number of patients alive(At 12 months from treatment start)
- Number of patients alive without progression of the disease(At 12 months from treatment start)