A Clinical Trial of PD-1 Monoclonal Antibody as First-line Induction Therapy for EBV-associated Hemophagocytic Syndrome (EBV-HLH) or Chronic Active EBV Infection (CAEBV)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- EBV-DNA viral load
研究概览
简要总结
EBV-HLH and CAEBV are both caused by EBV infection, part of them can rapidly lead to a syndrome of severe, life-threatening hyper-inflammation, with poor prognosis. Currently, the most effective treatment remains unknown. This study is trying to evaluate the efficacy and safety of PD-1 monoclonal antibody as a first-line therapy for EBV-HLH and CAEBV.
详细描述
Eligible patients who were diagnosed with EBV-HLH or CAEBV, age between 12 and 70 years, were enrolled in this study. All of them need to sign the informed consent first.
PD-1 monoclonal antibody 200mg is infused intravenously once for patients whose age >=18 years, or age <18 years but weight >=40kg. While for patients age <18 years, the dose of PD-1 monoclonal antibody is 3mg/kg. Besides, optimal supportive care is necessary.
Ruxolitinib and/or low-dose glucocorticoid can be used to reduce inflammation.
Cerebrospinal fluid parameters are examined, and methotrexate 15mg combined with dexamethasone will be intrathecal injected without contraindications.
Clinical and laboratory indicators are investigated weekly to evaluate the efficacy and toxicity.
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of EBV-HLH or CAEBV.
- •Newly diagnosed patients.
- •Eastern Cooperative Oncology Group score 0-
- •Total bilirubin <= 10 times of upper limit of normal (except for those caused by EBV-HLH or CAEBV), and serum creatinine <= 1.5 times of upper limit of normal.
- •Serum HIV antigen or antibody is negative.
- •Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV-RNA is negative.
- •Both HbsAg and HbcAb for Hepatitis B virus (HBV) are negative. If not, the quantification of HBV-DNA needs to be <1*10e3 IU/ml.
- •The patient or his/her guardian must be able to understand and be willing to participate in this study, and sign the informed consent.
排除标准
- •Non EBV-HLH or CAEBV patients.
- •Refractory or relapsed EBV-HLH or CAEBV.
- •Heart function above grade II (NYHA).
- •Patients suffered from other uncontrollable active infections.
- •Pregnant or lactating women.
- •Patients with mental disorders and cannot cooperate with the requirements of research, treatment and monitoring.
- •Active visceral bleeding.
- •Allergic to PD-1 monoclonal antibody.
- •Patients with known autoimmune diseases.
- •Participate in other clinical research at the same time.
- •The investigator judges that the patient has other reasons not suitable for this study, or participating in the study will bring great risks to the patient.
研究组 & 干预措施
PD-1 monoclonal antibody group
PD-1 monoclonal antibody 200mg is infused intravenously once for patients whose age >=18 years, or age <18 years but weight >=40kg. While for patients age <18 years, the dose of PD-1 monoclonal antibody is 3mg/kg.
干预措施: PD-1 monoclonal antibody (Drug)
结局指标
主要结局
EBV-DNA viral load
时间窗: 3 weeks
EBV-DNA copy by polymerase chain reaction
Response rate
时间窗: 3 weeks
complete response and/or partial response rate
次要结局
- Toxicity of PD-1 monoclonal antibody(3 weeks)
- Time for treatment works(3 weeks)