A Retrospective Observational Study to Evaluate the Clinical Outcomes and Routine Management of Patients With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 16
- 主要终点
- Overall Response Rate
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness of idelalisib and rituximab in adults with chronic lymphocytic leukaemia (CLL) in a real world setting
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 documented within medical records
- •Individuals who have received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation at the time of starting idelalisib treatment
- •Idelalisib and rituximab initiated on or before 31 December 2017
排除标准
- •Individuals who received idelalisib as part of an interventional clinical trial
- •Individuals who received idelalisib for other indications including follicular lymphoma (FL)
- •Individuals who previously received idelalisib in combination with ofatumumab
- •Use of idelalisib which is not in accordance with its marketing authorisation at the time of starting idelalisib treatment
研究组 & 干预措施
Idelalisib and Rituximab
Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation.
干预措施: Idelalisib (Drug)
Idelalisib and Rituximab
Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation.
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 3 months
Overall Response Rate (ORR) is defined as the proportion of participants who achieve a clinical response as documented within their patient records after the initiation of treatment with idelalisib and rituximab during the observation period.
次要结局
- Overall Safety and Tolerability of Idelalisib and Rituximab as Measured by the Incidence of Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)(Up to 3 months)
- Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib(Up to 3 months)
- Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective(Up to 3 months)
- Time to Next Treatment(Up to 3 months)
- Overall Survival(Up to 3 months)
- Progression-Free Survival(Up to 3 months)
- Duration of Response(Up to 3 months)
- Starting Dose of Idelalisib(Up to 3 months)