PD-1 Antibody for Reactive EBV After BMT
Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
1 other identifier
interventional
20
1 country
1
Brief Summary
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedJune 29, 2021
June 1, 2021
1.5 years
December 27, 2020
June 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
EBV-DNA turn negative
after treatment, the EBV-DNA copies can not be detected in peripheral blood
4 weeks after PD-1 antibody was used
Secondary Outcomes (1)
treatment-related adverse events as assessed by CTCAE v5.0
4 weeks after PD-1 antibody was used
Other Outcomes (1)
Survival
1 year
Study Arms (1)
one group
EXPERIMENTALAll patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment.
Interventions
when EBV-DNA is positive after allo-HCT, and EBV infected T/NK cell, one dose of toripalimab 3mg/kg would be used, the same dose would be repeated 4 weeks later.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhao Wang
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Hematology, Beijing Friendship Hospital
Study Record Dates
First Submitted
December 27, 2020
First Posted
December 30, 2020
Study Start
July 1, 2021
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
June 29, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share