EpcoReal: A Multi-country, Prospective Observational Study of Epcoritamab in NHL Comprising Two Patient Cohorts (3L+ (D)LBCL and 3L+ FL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 127
- 主要终点
- Percentage of Participants Achieving Overall Response (OR)
研究概览
简要总结
Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections) and the most common type of non-Hodgkin lymphoma. Follicular Lymphoma (FL) is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the real-world effectiveness of subcutaneous epcoritamab in adult participants with advanced DLBCL and FL.
Epcoritamab is an investigational drug being developed for treating participants with DLBCL and FL. Approximately 700 participants will be enrolled in approximately 80 sites across 12-20 countries globally.
Participants will receive epcoritamab as prescribed by their physician in accordance with local country label. Participants will be followed for up to 3 years.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine 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
- •Participants who are scheduled to be treated with epcoritamab for Treatment after two or more prior lines of therapy 3L+ diffuse large B-cell lymphoma ((D)LBCL) or 3L+ Follicular lymphoma (FL).
- •Treatment with epcoritamab should be administered in accordance with the approved local label in the participating country.
- •The decision to treat the participant should have been made by the clinician prior to, and independently of any decision to approach the participant to participate in this study.
排除标准
- •Any condition included in the contraindications section of the approved local epcoritamab label in the participating country.
- •Participation in a concurrent interventional clinical trial (not including non-interventional/ observational study, PMOS, or registry participation) from enrollment and throughout the study.
研究组 & 干预措施
Epcoritamab
Participants will receive epcoritamab as prescribed by their physician according to local label.
结局指标
主要结局
Percentage of Participants Achieving Overall Response (OR)
时间窗: Up to approximately 3 years
Defined as the percentage of participants who achieve best overall response of complete response (CR) or partial response (PR) determined by Lugano criteria
次要结局
未报告次要终点