Zanubrutinib Monotherapy in Patients With Hemophagocytic Lymphohistiocytosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- evaluation of treatment response
研究概览
简要总结
This study is a prospective single-arm clinical study, focusing on Hemophagocytic lymphohistocytosis，to evaluate the clinical efficacy and safety of zanubrutinib.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unlimited gender, age ≥ 14 years old;
- •HLH was diagnosed according to HLH-04 diagnostic criteria;
- •Before the study, there was no severe liver function injury; Serum creatinine ≤ 1.5 times the upper limit of normal value;
- •Sign informed consent
排除标准
- •Allergic to zebutinib;
- •Currently active important cardiovascular diseases with clinical significance; The functions of important organs such as heart and lung unrelated to HLH were seriously abnormal;
- •Known human immunodeficiency virus (HIV) or active hepatitis B (HBV) or hepatitis C (HCV) infection;
- •Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial;
- •Serious mental illness;
- •Active massive hemorrhage of internal organs;
- •Uncontrollable infection;
- •At the same time, participate in other clinical researchers
研究组 & 干预措施
zanubrutinib
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
evaluation of treatment response
时间窗: Change from before and 2,4,6 and 8 weeks after initiating therapy
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%.
Adverse events
时间窗: 6 months
Adverse events including myelosuppression, infection, hemorrhage
Progression Free Survival
时间窗: 6 months
from date of inclusion to date of progression, relapse, or death from any cause
次要结局
未报告次要终点
研究者
Zhao Wang
Principal Investigator
Beijing Friendship Hospital