NCT00148018终止2 期
A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Overall response rate (complete and partial responses)
研究概览
简要总结
The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.
详细描述
The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.
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
- •Hodgkin's lymphoma
- •Second or higher relapse (first relapse if high-dose chemotherapy not possible)
- •Age >/= 18 years
- •No major organ dysfunction or intercurrent disorder
- •Written informed consent
排除标准
- •Pregnant or nursing
结局指标
主要结局
Overall response rate (complete and partial responses)
次要结局
- Toxicity
- Event free survival
- Overall survival
- Duration of response
- Treatment administration (dose-intensity, total dose)
研究者
研究点 (2)
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