NCT06534463招募中不适用
The Effectiveness and Safety of Different Treatment Modalities in Real-World Clinical Practice Among Chinese Patients with Marginal Zone Lymphoma: a Prospective, Observational, Multi-center Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This study aims to evaluate real-world treatment modalities and their corresponding effectiveness and safety in Chinese patients with marginal zone lymphoma, while also exploratively analyzing patient characteristics and health-related quality of life.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed as MZL
- •Meet the treatment indications for MZL
排除标准
- •Any reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
结局指标
主要结局
Progression-free survival
时间窗: Baseline up to data cut-off (up to approximately 60 months)
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
次要结局
- Overall Response Rate(End of treatment visit (approximately 6 months))
- Complete Response Rate(End of treatment visit (approximately 6 months))
- Time to Next Treatment(From the start of treatment to the initiation of next-line treatment (up to approximately 60 months))
- Duration of Response(Baseline up to data cut-off (up to approximately 60 months))
- Duration of Complete Response(Baseline up to data cut-off (up to approximately 60 months))
- Overall survival(Baseline up to data cut-off (up to approximately 60 months))
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to data cut-off (up to approximately 60 months))
研究者
Zhao Weili
Deputy director of hospital
Ruijin Hospital
研究点 (1)
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