Status:
UNKNOWN
Rituximab Monotherapy for EBV-HLH and CAEBV
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Secondary Hemophagocytic Lymphohistiocytosis
Chronic Active Epstein-Barr Virus Infection
Eligibility:
All Genders
2-80 years
Phase:
PHASE3
Brief Summary
This study is a prospective single-arm clinical study, focusing on Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis and Chronic Active Epstein-Barr Virus Infection with only and mainly...
Eligibility Criteria
Inclusion
- Patients who meet the diagnostic criteria of EBV-HLH or CAEBV are confirmed to be mainly infected with B lymphocytes 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
- 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.
- Serum HIV antigen or antibody negative.
- HCV antibody negative, or HCV antibody positive, but HCV RNA negative.
- 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.
- LVEF ≥ 50% by cardiac echocardiography.
- 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.
- Informed consent obtained. -
Exclusion
- According to the New York Heart Association (NYHA) score, patients with heart disease of grade II or above (including grade II);
- Pregnant or lactating women and patients of childbearing age who refused to take appropriate contraceptive measures during this trial.
- Those who are allergic to rituximab ingredients or have more severe allergic constitution;
- Severe hypogammaglobulinemia.
- Active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.);
- Uncontrolled active infection (including lung infection, intestinal infection, etc.);
- 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.
- Severe mental illness;
- Patients who were not compliant during the trial and/or follow-up period.
- Concurrently participate in other clinical investigators.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05384743
Start Date
February 1 2022
End Date
April 1 2024
Last Update
May 20 2022
Active Locations (1)
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1
Zhao Wang
Beijing, China