An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 61
- 试验地点
- 28
- 主要终点
- Number of participants achieving an Objective Response Rate
研究概览
简要总结
Primary Objective:
Participants achieving an Objective Response Rate
Secondary Objective:
- Progression Free Survival
- Overall Survival
- Response Duration
- Safety
详细描述
The screening period = up to 4 weeks prior to SAR3419 administration
The treatment period = from the day of first administration of SAR3419 until the End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation - After therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of SAR3419 and ending with the End Of Treatment visit.
All patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR3419
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
干预措施: SAR3419 (Drug)
结局指标
主要结局
Number of participants achieving an Objective Response Rate
时间窗: 18 months
次要结局
- Number of participants with Adverse Events(Up to 1 year)
- Response duration - Time(Up to 18 months after the first infusion of the last patient)
- Overall Survival - Time(Up to 18 months after the first infusion of the last patient)
- Progression Free Survival - Time(Up to 18 months after the first infusion of the last patient)