A Non-interventional, Post-authorization Safety Study of Patients With Relapsed or Refractory Mantle Cell Lymphoma to Further Investigate and Characterize the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 105
- 试验地点
- 79
- 主要终点
- To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.
研究概览
简要总结
The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.
详细描述
This is a European multinational, retrospective, non-interventional study of participants with relapsed or refractory mantle cell lymphoma (R/R MCL). Potential sites will be identified where R/R MCL participants have been treated with lenalidomide. Site inclusion will be limited to countries where lenalidomide is reimbursed for this indication.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Received at least one dose of lenalidomide commencing after 08 July 2016 for the treatment of relapsed refractory mantle cell lymphoma.
- •Informed consent of the patient or an authorized third person or authority, if required by law, given prior to data collection.
- •Patient must be ≥18 years of age at the time of signing the informed consent form.
排除标准
- •Patients will be excluded if they were participating in an interventional clinical trial during the treatment period under observation in this Post Authorization Safety Study.
研究组 & 干预措施
Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe
干预措施: Lenalidomide (Drug)
结局指标
主要结局
To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.
时间窗: Approximately 8.5 years
To quantify and characterize the event of TFR by tumor burden (assessed based on the last CT scan performed within a maximum of 2 months prior to initiation of administration of lenalidomide) in R/R MCL patients treated with lenalidomide in a real-world setting.
次要结局
- To quantify and characterize the proportion of early deaths by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting(Approximately 8.5 years)