A Real-world Study: Efficacy and Safety of Selinexor-based Regimens for Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma
详细描述
this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with DLBCL or T cell lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Know and voluntarily sign the Informed Consent Form (ICF)
- •Clinically confirmed DLBCL, T or NK cell lymphoma
- •Patients with DLBCL or T or NK cell lymphoma who have used selinexor-based therapy in the past 3 months are included
- •Cooperate with clinical diagnosis and treatment management, and provide disease-related past medical history materials
排除标准
- •Previously received selinexor
- •Poor patient compliance
- •physicians evaluate that patients are not suitable for enrollment
研究组 & 干预措施
selinexor-based regimens
This study is a real-world study to explore the safety and efficacy of selinexor-based therapy in patients with lymphoma. It is planned to enroll 250 patients with lymphoma, including 150 patients with diffuse large B-cell lymphoma and 100 patients with peripheral T and NK/T-cell lymphoma.
干预措施: Selinexor (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: throughout the study, an average of 1 year
the percentage of patients with complete response and partial response
incidence of adverse events/ serious adverse events
时间窗: throughout the study, an average of 2 year
identify patterns of incidence in adverse events
次要结局
- incidence of dose delays or interruptions(throughout the study, an average of 2 year)