Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- EBV-DNA turn negative
研究概览
简要总结
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH
详细描述
Transplantaion is recongnized as a cure for CAEBV and EBV associated HLH，however, many patients undergo the reactivation of EBV after transpaltion, patiens may at high risk for recurrence of the disease. PD-1 is a promising therapy to solve this problem.
The present study was a one-arm clinical study, the main subject is to evaluate the effect of PD-1 antibody on the clearance of EBV
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 —（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; EBV-DNA in peripheral blood or EBER in tissue were positive, patients were diagnosed with EBV associated HLH (EBV-HLH). Chronic active EBV infection (CAEBV) was diagnosed by WHO criteria.
- •Undergo allo-HCT, have achieved full chimerism
- •Age >18 years old, gender is not limited.
- •After transplantation, EBV was reactivated and EBV-DNA was positive in blood
- •No secondary graft failure. (After grafted, ANC <0.5*10^9/l,PLT <10*10^9/l)
- •No uncontrollable infection
- •Withdraw immunosuppressor, no graft-versus-host disease was observed.
- •Before the start of the study, aminopherase (ALT/AST) and total bilirubin were normal. Serum creatinine ≤ 1.5 times the upper limit of Normal (ULN); No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal.
- •Informed consent.
排除标准
- •Allergic to toripalimab
- •Serious immunoreaction: myocardial damage, hepatitis, pneumonia
- •Central nervous system symptoms
- •Serious mental illness;
- •Active bleeding of the internal organs
- •Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
- •Participate in other clinical research at the same time.
研究组 & 干预措施
one group
All patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment.
干预措施: toripalimab injection (Drug)
结局指标
主要结局
EBV-DNA turn negative
时间窗: 4 weeks after PD-1 antibody was used
after treatment, the EBV-DNA copies can not be detected in peripheral blood
次要结局
- treatment-related adverse events as assessed by CTCAE v5.0(4 weeks after PD-1 antibody was used)
研究者
Zhao Wang
Department of Hematology, Beijing Friendship Hospital
Beijing Friendship Hospital