Splenectomy as a Treatment for Patient With Relapsed Haemophagocytic Lymphohistiocytosis of Unknown Etiology
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of treatment response
研究概览
简要总结
To evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic lymphohistiocytosis (HLH) in patient with unknown etiology.
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
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were older than 14 years of age
- •Diagnosed as Hemophagocytic Lymphohistiocytosis (HLH) according to HLH-
- •patients were excluded with infection, rheumatic and immunologic diseases, malignant tumors (especially lymphoma), and primary HLH.
- •Informed consent
排除标准
- •Pregnancy or lactating Women
- •Active bleeding of the internal organs
- •Uncontrollable infection
- •Contraindication of splenectomy
- •Participate in other clinical research at the same time
结局指标
主要结局
Evaluation of treatment response
时间窗: Change from before and1,2,4,8,12 and 24 weeks after splenectomy
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT). A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was\>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; for patients with an initial neutrophil count of\<0.5 ×109/L, a response was defined as an increase by at least 100% to\>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to \>2.0 × 109/L was considered a response; and for patients with ALT \>400 U/L, response was defined as an ALT decrease of at least 50%.
次要结局
- Adverse events that are related to treatment(through study completion, an average of 2 years)
- Survival(from the time patients received splenectomy up to 24 months or December 2018)
研究者
Zhao Wang
Doctor
Beijing Friendship Hospital