Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
Overview
- Phase
- Early Phase 1
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- EBV-DNA turn negative
Overview
Brief Summary
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
one group
All patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment.
Intervention: toripalimab injection (Drug)
Outcomes
Primary Outcomes
EBV-DNA turn negative
Time Frame: 4 weeks after PD-1 antibody was used
after treatment, the EBV-DNA copies can not be detected in peripheral blood
Secondary Outcomes
- treatment-related adverse events as assessed by CTCAE v5.0(4 weeks after PD-1 antibody was used)
Investigators
Zhao Wang
Department of Hematology, Beijing Friendship Hospital
Beijing Friendship Hospital