NCT02164500已完成2 期
A Phase II, Open-label, Prospective, Non-randomized, Multicenter Clinical Trial With the JAK-inhibitor Ruxolitinib in Patients With Relapsed or Refractory Classical Hodgkin 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
- 12
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The Purpose of this trial is:
- to determine the overall response rate (ORR, complete response [CR] + partial response [PR]) in patients with relapsed or refractory HL
- to determine the safety profile of ruxolitinib in patients with relapsed or refractory HL
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •relapsed or refractory HL
- •ECOG <= 2,
- •no major organ dysfunction
- •written informed consent
排除标准
- •history of another primary malignancy ≤ 2 years
- •female patients who are pregnant or breast feeding
- •patients with a known history of HIV seropositivity
- •chronic active hepatitis
研究组 & 干预措施
Ruxolitinib
Experimental
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
overall response rate
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Dr. Bastian von Tresckow
Dr.
University of Cologne
研究点 (1)
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