A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Overall response(complete response+ partial response) rate of Participants
研究概览
简要总结
This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older 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 EBV-Hemophagocytic Lymphohistiocytosis (HLH)
- •Patients did not receive any treatment for HLH before
- •Informed consent
排除标准
- •Heart function above grade II (NYHA)
- •Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
- •Pregnancy or lactating Women
- •Allergic to Pegaspargase, doxorubicin or etoposide
- •Active bleeding of the internal organs
- •uncontrollable infection
- •history of acute and chronic pancreatitis
- •Participate in other clinical research at the same time
研究组 & 干预措施
L-DEP
Pegaspargase 2000U/m2 day5; doxorubicin hydrochloride liposome injection 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
干预措施: Etoposide (Drug)
L-DEP
Pegaspargase 2000U/m2 day5; doxorubicin hydrochloride liposome injection 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
干预措施: Pegaspargase (Drug)
L-DEP
Pegaspargase 2000U/m2 day5; doxorubicin hydrochloride liposome injection 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
干预措施: doxorubicin hydrochloride liposome injection (Drug)
L-DEP
Pegaspargase 2000U/m2 day5; doxorubicin hydrochloride liposome injection 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
干预措施: methylprednisolone (Drug)
HLH-94 regimen
Etoposide 150 mg/m2 twice weekly for 2 weeks and then weekly; dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
干预措施: Etoposide (Drug)
HLH-94 regimen
Etoposide 150 mg/m2 twice weekly for 2 weeks and then weekly; dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
干预措施: dexamethasone (Drug)
结局指标
主要结局
Overall response(complete response+ partial response) rate of Participants
时间窗: Change from before and 2,4,6 and 8 weeks after initiating L-DEP or HLH-94 therapy
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25(pg/ml), ferritin(μg/L), and triglyceride(mmol/L); hemoglobin(g/L); neutrophil counts(×109/L); platelet counts(×109/L); and alanine aminotransferase (ALT(U/L)). A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25(pg/ml) response was\>1.5-fold decreased; ferritin (μg/L)and triglyceride(mmol/L) 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 (U/L)decrease of at least 50%.
次要结局
- Compare survival between two arms(from the time patients received L-DEP or HLH-94 therapy up to 12 months or September 2019)
- Change of Epstein-Barr virus(EBV)-DNA before and after therapy(Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP or HLH-94 therapy)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(through study completion, an average of 1 years)
研究者
Zhao Wang
Doctor
Beijing Friendship Hospital