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

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

NCT ID: NCT05841342

Condition: Secondary Hemophagocytic Lymphohistiocytosis
Chronic Active Epstein-Barr Virus Infection

Conditions: Official terms:
Infections
Virus Diseases
Epstein-Barr Virus Infections
Lymphohistiocytosis, Hemophagocytic

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: No intervention
Description: No intervention
Arm group label: CAEBV or EBV-HLH Patients
Arm group label: Healthy Control

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.

Criteria for eligibility:

Study pop:
Healthy people and patients with CAEBV or secondary EBV-HLH.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 2 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Beijing Friendship Hospital, Capital Medical University

Address:
City: Beijing
Zip: 100050
Country: China

Status: Recruiting

Contact:
Last name: Zhao Wang, MD

Phone: 63138303
Email: zhaowww263@yahoo.com

Start date: October 1, 2022

Completion date: June 30, 2024

Lead sponsor:
Agency: Beijing Friendship Hospital
Agency class: Other

Source: Beijing Friendship Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05841342