NCT06481826招募中不适用
A Study to Evaluate Glofitamab as Single Agent in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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
- 20
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed DLBCL
- •Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy
- •Participants must have measurable disease
排除标准
- •Pregnancy or breastfeeding
- •Patient with known active infection, or reactivation of a latent infection
- •Patient with active autoimmune disease or immune deficiency
- •severe organ failure：LVEF<40%；DLCO<40%；eGFR<30ml/min；Bilirubin≥3ULN
- •Patients who are dependent on the sponsor, the investigator or the trial site
研究组 & 干预措施
treatment group
Glofitamab
干预措施: Glofitamab (Drug)
结局指标
主要结局
PFS
时间窗: 1 year
Progression-free survival
次要结局
- ORR(6 weeks, 18 weeks, 36 weeks)
- OS(2 year)
- DOR(2 year)
- AE(2 year)
- CR rate(6 weeks, 18 weeks, 36 weeks)
研究者
研究点 (1)
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