Chidamide Combines With Etoposide and Methylprednisolone in the Treatment of Hemophagocytic Lymphohistiocytosis
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of treatment response
研究概览
简要总结
Chidamide combines with VP-16 and methylprednisolone in HLH
详细描述
This study aimed to investigate the efficacy and safety of Chidamide together with Etoposide and methylprednisolone for hemophagocytic lymphohistiocytosis
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 65 Years（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; patients were diagnosed with EBV associated HLH (EBV-HLH) and lymphoma associated HLH.Age ≥18 years old, gender is not limited. Serum creatinine ≤ 1.5 times normal；NT-proBNP ≤ normal；Informed consent obtained.
排除标准
- •Active bleeding of the internal organs or patients with new thrombotic diseases；Allergic to Chidamide and etoposide；Participate in other clinical research at the same time；HIV , HBV and HCV infected patients (HIV antibody positive)；History of QT interval prolongation, atrioventricular block, ventricular tachycardia, coronary atherosclerotic heart disease；Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial. If the patient was male, he refused to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study；patients judged by the investigator to be unsuitable to participate in this study.
研究组 & 干预措施
Assigned Interventions
Chidamide combines with VP-16 and methylprednisolone
干预措施: Chidamide combines with VP-16 and methylprednisolone (Drug)
结局指标
主要结局
Evaluation of treatment response
时间窗: 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
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%.Overall response rate (ORR) is defined as the ratio of patients with CR and PR to overall patients
次要结局
- the response rate of lymphoma(4 weeks after Chidamide combines with VP-16 and methylprednisolone was used)
- EBV-DNA copies(4 weeks after Chidamide combines with VP-16 and methylprednisolone was used)
- relapsed rate of HLH(4 weeks after Chidamide combines with VP-16 and methylprednisolone was used)