NCT04120090Unknown3 期
Clinical Study of Different Doses of Ruxolitinib as a Salvage Therapy for Refractory/Relapsed Hemophagocytic Lymphohistiocytosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This study aimed to investigate the efficacy and safety of different doses of ruxolitinib as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis(HLH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;
- •treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least PR; or relapsed patients after remission；
- •Life expectancy exceeds 1 month;
- •Age≥1 year old and ≤75 years old, gender is not limited；
- •Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal；
- •Serum human immunodeficiency virus(HIV) antigen or antibody negative；
- •Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；
- •Both hepatitis B virus (HBV) surface antigen and HBV core antibody were negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer should be detected, and less than 1×103 copies/ml can enter the group；
- •Informed consent.
排除标准
- •Pregnancy or lactating Women；
- •Allergic to ruxolitinib；
- •Active bleeding of the internal organs；
- •uncontrollable infection；
- •Serious mental illness;
- •Non-melanoma skin cancer history;
- •Patients unable to comply during the trial and/or follow-up phase;
- •Participate in other clinical research at the same time.
研究组 & 干预措施
Low dose
Active Comparator
干预措施: low dose ruxolitinib (Drug)
High dose
Experimental
干预措施: high dose ruxolitinib (Drug)
结局指标
主要结局
Response rate
时间窗: 1 years
complete response (CR) and partial response (PR) rates
Progression Free Survival
时间窗: 1 years
from date of inclusion to date of progression, relapse, or death from any cause Overall Survival
次要结局
- Overall Survival(1 years)
- Adverse events(1 year)
研究者
Zhao Wang
Clinical Professor
Beijing Friendship Hospital
研究点 (1)
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