NCT00072449终止2 期
A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins18 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2004年5月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 18
- 主要终点
- Radiographic Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab.
Secondary
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
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
结局指标
主要结局
Radiographic Response
时间窗: 1 month, 2 months and then q3months
it at any time point patient progresses no more scans are required, patient is off study
次要结局
- Progression-free Survival(pt had MRI q3months)
- Overall Survival(47 months)
- Toxicity(8 weeks - 2 cycles)
研究者
研究点 (18)
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