Status:
UNKNOWN
PD-1 Antibody for Reactive EBV After BMT
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
PD-1
EBV Infection
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 disea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04690036
Start Date
July 1 2021
End Date
January 1 2023
Last Update
June 29 2021
Active Locations (1)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050