An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MorphoSys AG
- 入组人数
- 490
- 试验地点
- 2
- 主要终点
- Best overall/objective response rate (ORR)
研究概览
简要总结
This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)
详细描述
Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.
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 DLBCL
- •Relapsed/refractory to at least one previous systemic therapy for DLBCL
- •Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
- •Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT
排除标准
- •CNS involvement by lymphoma
- •Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
- •Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
- •Patients who previously underwent allogeneic SCT
- •Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
- •Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start
结局指标
主要结局
Best overall/objective response rate (ORR)
时间窗: Through study completion, an average of 9 months
Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study
次要结局
- Overall survival(Through study completion, an average of 9 months)
- Disease control rate(Through study completion, an average of 9 months)
- Complete response rate(Through study completion, an average of 9 months)