NCT00794638已完成1 期
A Multicenter Phase I Clinical Trial to Assess the Safety of Two Consecutive Days of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aggressive B-cell non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
- •Patients with the following histologically confirmed CD20(+) B-cell non-Hodgkin's lymphoma:
- •Diffuse large B-cell lymphoma
- •Mantle cell lymphoma
- •Transformed lymphoma
- •Follicular lymphoma (Grade 3)
- •Fail to CR in prior chemotherapy, or relapse following CR or recurrence following PR.
- •Patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.
- •Patients aged from 20 to 75 years at the time informed consent is obtained
- •Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
- •Patients who can be hospitalized during the first cycle
- •Patients capable of personally giving voluntary informed consent in writing to participate in the study
排除标准
- •Patients who meet any of the following criteria will be excluded.
- •Patients with serious complications (hepatic or renal failure)
- •Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)
- •Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
- •Patients positive for HBs antigen, HCV antibody, or HIV antibody
- •Patients who received other investigational drug or unapproved medication within 3 months before registration in this study
- •Patients who had history of hematopoietic stem cell transplantation or radioimmunotherapy
- •Patients who are pregnant, of childbearing potential, or lactating
- •Patients, whether male or female, who do not agree to contraception
- •Patients otherwise judged by investigator or sub investigator to be unsuitable
结局指标
主要结局
Dose-limiting toxicity
时间窗: Treatment period
次要结局
- CR rate and the overall response rate, determination by Independent Review Committee(Treatment period)
研究者
研究点 (4)
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