An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Siltuximab for Patients with Castleman's Disease Treated in Italy in a Real-life Context
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 12
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
The study is a pilot, observational, retrospective, and (italian) multicenter study.
The study will involve the collection of patient data from medical records for patients with Multicentric Castelman Disease Relapsed/Refractory who received treatment with at least one dose of siltuximab, as part of standard of care in a real-life context, from July 2016 till April 2022 in 31selected italian centres.
详细描述
The aim of the present study is to provide useful information about use, effectiveness, and safety profile of siltuximab given to relapsed or refractory (R/R) MCD in a real-life context since approval as more data are needed to improve knowledge in this rare disease. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. Infact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.
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
- •Histologically confirmed diagnosis of R/R MCD HIV and HHV-8 negative patients who underwent siltuximab in a real-life context from July 2016 till April
- •Age ≥ 18 yearsatenrollment
- •Signature of written informed consent (where applicable)
排除标准
- •R/R MCD patients who underwent siltuximab in a clinical trial context
结局指标
主要结局
overall response rate (ORR)
时间窗: after the end of siltuximab infusion
Primarily this study aims to evaluate retrospectively effectiveness in terms of ORR of siltuximab as a single agent in patients with R/R MCD treated with at least one dose of siltuximab in a real-life context
次要结局
- Overall Survival (OS)(before, during and after the end of siltuximab infusion)
- Duration of response (DoR)(before, during and after the end of siltuximab infusion)
- Progression-free survival (PFS)(before, during and after the end of siltuximab infusion)
- Duration Free Survival (DFS)(before, during and after the end of siltuximab infusion)
- Best response rate (BRR)(before, during and after the end of siltuximab infusion)
- safety and tolerability of siltuximab(before, during and after the end of siltuximab infusion)