Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- overall response rate（ORR）
研究概览
简要总结
This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.
详细描述
Available data have shown that the combination of obinutuzumab and lenalidomide has shown good efficacy and safety in patients with R/R FL, but the efficacy and safety in Chinese patients remain to be verified.
This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.
The main questions it aims to answer are:
- To assess the ORR in the R/R FL patient population treated with the combination of obinutuzumab and lenalidomide
- To assess CRR, PFS, EFS, DOR, OS, and safety in patients with R/R FL treated with the combination of obinutuzumab and lenalidomide
Participants in this study will not and should not result in any intervention to the patient's treatment and visits. All treatments and visits for patients will be at the physician's discretion according to clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- •Patients currently participating or planning to participate in any interventional clinical trial
- •Any other reason that, in the opinion of the investigator, makes the patient unsuitable for this study
结局指标
主要结局
overall response rate（ORR）
时间窗: 24 weeks
Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.
次要结局
- 2-year Progression free survival（PFS24）(Up to 4.5 years)
- 2-year Event-free survival（EFS24）(Up to 4.5 years)
- Complete response (CR)(2.5 years)
- Duration of response (DoR)(Up to 4.5 years)
- Overall survival (OS)(Up to 4.5 years)
- Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities)(4.5 years)