NCT00285428已完成1 期
A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Safety and tolerance of different dose levels
研究概览
简要总结
This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.
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
- •CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
排除标准
- 未提供
研究组 & 干预措施
Dose level 1
Experimental
120 mg/m2
干预措施: hA20-humanized anti-CD20 antibody (Drug)
Dose level 2
Experimental
200 mg/m2
干预措施: hA20-humanized anti-CD20 antibody (Drug)
Dose Level 3
Experimental
375 mg/m2
干预措施: hA20-humanized anti-CD20 antibody (Drug)
Dose level 1B
Experimental
80 mg/m2
干预措施: hA20-humanized anti-CD20 antibody (Drug)
结局指标
主要结局
Safety and tolerance of different dose levels
时间窗: 12 weeks
次要结局
- Lack of immunogenicity(8 and 12 weeks)
- Pharmacodynamics(over 12 weeks)
- Pharmacokinetics(over 12 weeks)
- Efficacy(4, 8 and 12 wks, every 3 months)
研究者
研究点 (3)
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