NCT06497452招募中不适用
A Prospective, Observational Study to Explore the Efficacy and Safety of Salvage Therapy With Glofitamab in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma.
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
- •Be diagnosed as B-NHL
- •Relapse or refractory to previous treatment
- •Participants who will be treated with glofitamab
排除标准
- •Participant who currently participates in or with plan to participate in any interventional clinical trial
- •Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
研究组 & 干预措施
Observational Cohort
干预措施: Glofitamab (Drug)
结局指标
主要结局
Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
时间窗: Baseline up to EOT (approximately 9 months)
次要结局
- Best Overall Response Rate (bORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma(Baseline up to EOT (approximately 9 months))
- Duration of Response (DoR)(From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months))
- Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma(From the start of glofitamab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 24 months))
- Duration of Complete Response (DoCR)(From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months))
- PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma(Baseline up to end of study (approximately 24 months))
- Overall Survival (OS)(From the start of glofitamab treatment until the date of death from any cause (up to approximately 24 months))
- Time to Next Treatment (TTNT)(From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 24 months))
研究者
研究点 (1)
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