NCT01392716已完成2 期
An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Overall objective complete response rate
研究概览
简要总结
This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18-75 years of age
- •Newly diagnosed non-bulky follicular non-Hodgkin's lymphoma
- •>/=1 measurable lesion
- •No prior treatment (no corticosteroids or radiotherapy)
排除标准
- •Transformed follicular lymphoma
- •Cerebral or meningeal lymphomaotus localization
- •Uncontrolled concurrent infection
研究组 & 干预措施
Single arm
Experimental
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Overall objective complete response rate
时间窗: Day 50
Overall objective partial response rate
时间窗: Day 50
次要结局
- Progression-free survival(7 years)
- Overall survival(7 years)
- Level of biological marker bcl2 in peripheral blood and bone marrow(7 years)
- Duration of response(7 years)
- Safety: Incidence of adverse events(7 years)
研究者
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