NCT00796731已完成1 期
A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive 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
- 77
- 试验地点
- 12
- 主要终点
- Incidence of DLT(s) at each dose level
研究概览
简要总结
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.
Secondary objectives are:
- to characterize the global safety profile
- to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
- to assess preliminary evidence of anti-lymphoma activity.
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
- •Diagnosis of B-cell non Hodgkin's lymphoma
- •Relapsed or refractory after standard treatments and with no curative option with conventional therapy (Patients having undergone stem cell transplantation may be included)
- •CD19 positive disease by flow cytometry or immunohistochemistry
排除标准
- •Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
- •Evidence of cerebral or meningeal involvement by lymphoma
- •Patients without bi-dimensionally measurable disease
- •ECOG performance status > 2
- •Life expectancy less than 3 months
- •Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
- •Previous radioimmunotherapy within 12 weeks
- •Known anaphylaxis to infused proteins
- •HIV, HBV and HCV positivity
- •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 the compliance with the study
- •Pregnant or breast-feeding women
- •Patients 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 DLT(s) at each dose level
时间窗: during the initial 3-week period of treatment
次要结局
- Pharmacokinetics parameters(Study period)
- Cumulative DLT(s)(over the entire period of treatment)
- Incidence of Adverse Events and laboratory abnormalities(study period)
- Tumor response (complete response, partial response) and duration of the response(study period)
研究者
研究点 (12)
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