Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 25
- 主要终点
- Efficacy Endpoints
研究概览
简要总结
This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting.
详细描述
This study was a prospective, multicenter, non-interventional, real-world study. The study will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and < 60 years at the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of treatment). Patients in this study will receive obinutuzumab-contained regimens according to the investigators' clinical opinion.
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
- •Age: Age ≥ 18 years at the start of treatment;
- •Be diagnosed with grade 1-3a follicular Lymphoma, Marginal zone lymphoma;
- •Previously untreated or relapsed or refractory patients;
- •Patients who started treatment with otuzumab between June 2021 and April 2023.
排除标准
- •Patients currently participating or planning to participate in any interventional clinical trial;
- •Patients who, in the opinion of the investigator, are Discomfort for any other reason to participate in this study.
研究组 & 干预措施
Cohort 1
the younger cohort (aged ≥ 18 and < 60 years at the start of treatment)
干预措施: Obinutuzumab (Drug)
Cohort 2
the older cohort (aged ≥ 60 years at the start of treatment)
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Efficacy Endpoints
时间窗: 12 months
The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS.
次要结局
- Safety Endpoints(12 months)
研究者
Wenyu Shi
Director, Department of Oncology
Affiliated Hospital of Nantong University