A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- Overall response Rate (ORR) according to Cheson 2007
研究概览
简要总结
Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in patients with advanced Hodgkin's lymphoma for whom no curative option is available.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ruxolitinib
Induction period: Ruxolitinib will be given twice daily during 6 cycles of 28 days.
Maintenance period: patients who achieve at least a stable disease (according Cheson 2007) at the end of cycle 6 and for whose a clinical benefit is observed according to the Investigator's opinion will be eligible for maintenance treatment by ruxolitinib twice daily every day of 28-day cycles.
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Overall response Rate (ORR) according to Cheson 2007
时间窗: 6 months
Overall Response Rate according to the International Working Group criteria (Cheson 2007) is defined as patient with Complete response or Partial response. Patient without response assessment (due to whatever reason) will be considered as non responder.
次要结局
- Overall response rate (ORR) according to Cheson 1999(6 months)
- Complete response rates (CR) according to Cheson 2007 and 1999(2 months, 4 months and 6 months)
- Best Response Rate (BRR) according to Cheson 1999 and 2007(6 months)
- Safety endpoints(30 months)
- Time to response(Up to 30 months)
- Duration of response(Up to 4.5 years)
- Progression Free Survival (PFS)(Up to 4.5 years)
- Overall Survival (OS)(Up to 4.5 years)
- Evaluation of systemic symptoms(Up to 30 months)