NCT01470456已完成2 期
An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 50
- 试验地点
- 13
- 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 (Cheson 2007)
Secondary Objectives:
- Progression Free Survival
- Overall Survival
- Response Duration
详细描述
- The screening period = up to 4 weeks prior to the first administration of combined therapy
- The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients.
- The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival.
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 + Rituximab
Experimental
Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.
干预措施: SAR3419 (Drug)
SAR3419 + Rituximab
Experimental
Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.
干预措施: rituximab (Drug)
结局指标
主要结局
Number of participants achieving an Objective Response Rate
时间窗: 18 weeks
次要结局
- Number of participants with Adverse Events(Up to 6 months)
- Response Duration -Time(Up to 24 months after the first infusion of the last patient)
- Overall survival -Time(Up to 24 months after the first infusion of the last patient)
- Progression Free Survival -Time(Up to 24 months after the first infusion of the last patient)
研究者
研究点 (13)
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