NCT00549185已完成1 期
An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Incidence of Dose Limiting Toxicity(ies) at each tested dose level
研究概览
简要总结
The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed CD19-positive non-Hodgkin's B-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy
- •ECOG performance status 0 to 2
排除标准
- •Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
- •Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
- •Previous radioimmunotherapy within 12 weeks
- •Known intolerance to infused protein products or maytansinoids
- •Poor kidney, liver and bone marrow functions
- •Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
- •Pregnant or breast-feeding women
- •Patient with reproductive potential without effective birth control methods
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
时间窗: Study period
次要结局
- Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response(Study period)
- Incidence of Adverse Events(Study period)
研究者
研究点 (2)
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