Ruxolitinib Combined With Dexamethasone for Pediatric Refractory and Secondary Hemophagocytic Lymphohistiocytosis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Severity of disease
研究概览
简要总结
A protocol named as "HLH-DR" for patients with refractory and secondary hemophagocytic lymphohistiocytosismay.
详细描述
A modified protocol about ruxolitinib combined with dexamethasone which includes oral ruxolitinib (2.5 mg twice daily for patients if the age<14 years and the weight <25kg，5 mg twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and<18 years）. Dexamethasone (10mg/m2.d) delayes for the first 2 weeks （form week 1 to 2），(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8. Every 2 weeks, patients can be evaluated based the diagnosed index
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Secondary and refractory HLH.
排除标准
- •Family HLH.
研究组 & 干预措施
Ruxolitinib and Placebo
Ruxolitinib 2.5 mg twice daily by oral
干预措施: Ruxolitinib (Drug)
Ruxolitinib and Placebo
Ruxolitinib 2.5 mg twice daily by oral
干预措施: Dexamethasone (Drug)
Placebo and Ruxolitinib
Sugar pill 2.5 mg twice daily by oral
干预措施: Ruxolitinib (Drug)
Placebo and Ruxolitinib
Sugar pill 2.5 mg twice daily by oral
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Severity of disease
时间窗: 2 weeks
Serum ferritin\>2000ng/ml, disease actvie; serum ferritin\<2000ng/ml, disease control;
次要结局
- Axillary temperature(2 weeks)
研究者
Yan Yue
Principal Investigator
Capital Research Institute of Pediatrics