NCT07200375招募中不适用
Evaluating Effectiveness and Safety of Glofitamab Based Second-Line Therapy in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Cohort Study
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
- 入组人数
- 300
- 试验地点
- 23
- 主要终点
- real-world Progression-Free Survival (rwPFS)
研究概览
简要总结
This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
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
- •Histologically confirmed R/R DLBCL after one line of systemic therapy
- •Will be treated with Glofit-based regimen (known as being recommended and having the intention to be treated with Glofitamab at the time of signing ICF) or have initiated Glofit-based regimen treatment within three months (90 days) prior to enrollment
排除标准
- •Participants who currently participate in or plan to participate in any interventional clinical trial
研究组 & 干预措施
Glofitamab treatment
Participants will be enrolled into the study either prior to initiation of glofitamab therapy or within 90 days of starting glofitamab therapy.
干预措施: Glofitamab (Drug)
结局指标
主要结局
real-world Progression-Free Survival (rwPFS)
时间窗: Up to approximately 4 years
次要结局
- Complete Response Rate (CRR)(Up to approximately 4 years)
- Event-Free Survival (EFS)(Up to approximately 4 years)
- Overall Response Rate (ORR)(Up to approximately 4 years)
- Disease Control Rate (DCR)(Up to approximately 4 years)
- Duration of Response (DoR)(Up to approximately 4 years)
- Duration of Complete Response (DoCR)(Up to approximately 4 years)
- Overall Survival (OS)(Up to approximately 4 years)
- Time to Next Treatment (TTNT)(Up to approximately 4 years)
研究者
研究点 (23)
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