NCT00168740已完成3 期
Pivotal Phase III Multi-Center Study to Evaluate the Safety and Efficacy of Once Weekly Times Four Dosing of IDEC-C2B8 (IDEC-102) in Patients With Relapsed Low-Grade or Follicular B-Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 150
- 试验地点
- 33
- 主要终点
- overall response rate
研究概览
简要总结
Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11.2 months.
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
- •Diagnosis of relapsed, low-grade or follicular B-cell lymphoma
- •CD20-positive lymphoma
- •Progressive, measurable disease
- •Sign informed consent
- •3 weeks beyond standard therapy
- •Good performance status
- •Adequate hematologic, renal, and hepatic function
排除标准
- •Chronic lymphocytic leukemia
- •Lesions greater than or equal to 10 cm in diameter
- •CNS lymphoma
- •AIDS-related lymphoma
- •Pleural effusions or ascites secondary to lymphoma
- •Active, opportunistic infection
- •Serious nonmalignant disease
- •Prior investigational therapies, including prior anti-CD20 therapy
- •Recent major surgery
结局指标
主要结局
overall response rate
次要结局
- time to disease progression
- progressive disease-free interval
研究者
研究点 (33)
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