NCT04084626Unknown3 期
A Clinical Trial of Programmed Cell Death Protein 1(PD1) Antibody and Lenalidomide as a Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis or Chronic Active EBV Infection(CAEBV)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The present study was a prospective one-arm clinical study, in which EBV-HLH/chronic active EBV infection patients were selected as the main subjects to evaluate the effect of PD-1 antibody and lenalidomide regimens on ebv-dna and safety.
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
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.
- •If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.
- •A woman of childbearing age must be determined not to be pregnant by a pregnancy test and is willing to take effective measures to prevent pregnancy during the trial period and ≥12 months after the last administration of the drug; All male subjects used contraceptive methods during the study period and ≥6 months after the last administration;
- •Ages Eligible for Study: 1 Year to 65 Years.
- •Sign the informed consent.
排除标准
- •Heart function above grade II (NYHA).
- •Pregnancy or lactating Women.
- •Allergic to PD-1 antibody or lenalidomide.
- •Active bleeding of the internal organs.
- •uncontrollable infection.
- •Participate in other clinical research at the same time.
研究组 & 干预措施
PD-1 antibody
Experimental
PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.
干预措施: PD1 antibody (Drug)
PD-1 antibody
Experimental
PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.
干预措施: lenalidomide (Drug)
结局指标
主要结局
Response rate
时间窗: 6 months
The rate of decline in EBV-DNA copy (defined as a 2log decrease in EBV-DNA copy) or negative rate in peripheral blood mononuclear cells and plasma
次要结局
- Spleen size(6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(through study completion, an average of 1 years)
- survival(1 year)
研究者
Zhao Wang
Principal Investigator
Beijing Friendship Hospital
研究点 (1)
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