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Prospective Study of Immune Function and PD-1 Antibody Therapy Efficacy Predictors on CAEBV and EBV-HLH Patients

A Prospective Study of Immune Function and PD-1 Antibody Therapy Efficacy Predictors for Chronic Active Epstein-Barr Virus Infection and Epstein-Barr Virus Associated Hemophagocytic Lymphohistiocytosis

NCT05841342•Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

This prospective case-control study aims to evaluate the immune function and find PD-1 antibody efficacy predictors on Chronic Active Epstein-Barr Virus Infection and Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis by detecting lymphocyte subsets proportions in peripheral blood mononuclear cells and the positive proportion of PD-1, PD-L1 and other indicators in each lymphocyte subsets in healthy people and patients using flow cytometry before and after the initial PD-1 therapy.

Eligibility

Age

2 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Patients who meet the diagnostic criteria of EBV-HLH or CAEBV (except B lymphocytes involvement only) after the detection of EBV lymphocyte subsets. EBV-HLH diagnostic 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). CAEBV diagnostic criteria: (1) persistent or recurrent infectious mononucleosis-like symptoms persisting for more than 3 months; (2) EBV-DNA quantitative increase in peripheral blood or tissue lesions; (3) exclusion of other possible Diagnosis, such as primary Epstein-Barr virus infection (infectious mononucleosis), autoimmune disease, congenital immunodeficiency, human immunodeficiency virus (HIV) infection, or other underlying conditions requiring immunosuppressive therapy or underlying immunosuppression.
•2. Before the start of the study, total bilirubin ≤10 times the upper limit of normal, serum creatinine ≤1.5 times the normal value; fibrinogen can be corrected to ≥0.6g/L after infusion.
•3. Serum HIV antigen or antibody negative.
•4. HCV antibody negative, or HCV antibody positive, but HCV RNA negative.
•5. HBV surface antigen and HBV core antibody are both negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer detection is required, and the number of copies less than 1×103 copies/ml can be included in the group.
•6. LVEF ≥ 50% by cardiac echocardiography.
•7. Women of childbearing age must be confirmed by a pregnancy test that they are not pregnant, and are willing to take effective contraceptive measures during the test period and within ≥ 12 months after the last dose. Women during pregnancy and lactation cannot participate. Contraceptive measures should be taken during the test period and within ≥3 months after the last dose.
•8. Informed consent obtained.

Exclusion Criteria

•1. According to the New York Heart Association (NYHA) score, patients with heart disease of grade II or above (including grade II);
•2. Pregnant or lactating women and patients of childbearing age who refused to take appropriate contraceptive measures during this trial.
•3. Those who are allergic to rituximab ingredients or have more severe allergic constitution;
•4. Severe hypogammaglobulinemia.
•5. Active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.);
•6. Uncontrolled active infection (including lung infection, intestinal infection, etc.);
•7. HBV surface antigen and/or HBV core antibody are positive, and the peripheral blood hepatitis B virus DNA test confirms the existence of active hepatitis B patients.
•8. Severe mental illness;
•9. Patients who were not compliant during the trial and/or follow-up period.
•10. Concurrently participate in other clinical investigators.

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

October 1, 2022

Primary Completion Date

April 30, 2024

Completion Date

June 30, 2024

Last Updated

May 3, 2023

Enrollment

128

ESTIMATED participants

Conditions

Secondary Hemophagocytic LymphohistiocytosisChronic Active Epstein-Barr Virus Infection

Interventions

No intervention

OTHER

Contacts

Zhao Wang

CONTACT

86-010-63139862 zhaowww263@yahoo.com

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COMPLETEDPHASE2

Reduced Intensity Conditioning for Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (BMT CTN 1204)

NCT01998633

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Prospective Study of Immune Function and PD-1 Antibody Therapy Efficacy Predictors on CAEBV and EBV-HLH Patients

Inclusion Criteria

Exclusion Criteria

A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT

Reduced Intensity Conditioning for Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (BMT CTN 1204)

Rituximab Monotherapy for EBV-HLH and CAEBV