NCT06929624进行中（未招募）3 期
A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 282
- 试验地点
- 4
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 diffuse large B-cell lymphoma (DLBCL).
- •Have received ≥1 line of systemic antitumor therapy.
- •At least one bi-dimensionally measurable lesion.
- •Expected survival of at least 3 months.
- •Age ≥18 years old and under 80 years old.
- •The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.
排除标准
- •Central nervous system lymphoma involvement.
- •Primary mediastinal (thymus) large B-cell lymphoma.
- •Patients who have only one prior line therapy and are candidates for stem cell transplantation.
- •A history of immunodeficiency.
- •A history of severe cardiovascular disease.
- •A history of other malignancies within 5 years prior to administration of the first dose.
研究组 & 干预措施
SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
Experimental
干预措施: SHR-A1912 Injection (Drug)
SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
Experimental
干预措施: Oxaliplatin Injection (Drug)
Rituximab + Gemcitabine + Oxaliplatin
Active Comparator
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
Rituximab + Gemcitabine + Oxaliplatin
Active Comparator
干预措施: Rituximab Injection (Drug)
SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
Experimental
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
Experimental
干预措施: Rituximab Injection (Drug)
Rituximab + Gemcitabine + Oxaliplatin
Active Comparator
干预措施: Oxaliplatin Injection (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 5 years following the first dose of the last enrolled patient.
Complete response rate (CRR)
时间窗: Up to 1 years following the first dose of the last enrolled patient.
次要结局
- Adverse events (AEs)(Up to 5 years following the first dose of the last enrolled patient.)
研究者
研究点 (4)
Loading locations...
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