Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PD-1 Antibody for Reactive EBV After BMT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04690036
Recruitment Status : Not yet recruiting
First Posted : December 30, 2020
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Zhao Wang, Beijing Friendship Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH

Condition or disease Intervention/treatment Phase
PD-1 EBV Infection Transplant Drug: toripalimab injection Early Phase 1

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: one group
All patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment.
 Drug: toripalimab injection
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.
Other Name: EBV-DNA positive


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 4 weeks after PD-1 antibody was used ]
    Adverse events including thyroid function，liver function damage, myelosuppression, infection, bleeding and so on


Other Outcome Measures:
  1. Survival [ Time Frame: 1 year ]
    From enrollment until death or the end of the experiment


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Undergo allo-HCT, have achieved full chimerism
  3. Age >18 years old, gender is not limited.
  4. After transplantation, EBV was reactivated and EBV-DNA was positive in blood
  5. No secondary graft failure. (After grafted, ANC <0.5*10^9/l,PLT <10*10^9/l)
  6. No uncontrollable infection
  7. Withdraw immunosuppressor, no graft-versus-host disease was observed.
  8. 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.
  9. Informed consent.

Exclusion Criteria:

  1. Allergic to toripalimab
  2. Serious immunoreaction: myocardial damage, hepatitis, pneumonia
  3. Central nervous system symptoms
  4. Serious mental illness;
  5. Active bleeding of the internal organs
  6. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
  7. Participate in other clinical research at the same time.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690036


Contacts
Layout table for location contacts
Contact: Zhao Wang 86-010-63139862 wangzhao@ccmu.edu.cn
Contact: Yahong You 16810283962 15332022659@163.com

Locations
Layout table for location information
China, Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
Layout table for investigator information
Principal Investigator: Zhao Wang Beijing Friendship Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Zhao Wang, Department of Hematology, Beijing Friendship Hospital, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT04690036    
Other Study ID Numbers: PD-1,reactive EBV
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
 Virus Diseases
Infections
Tumor Virus Infections