NCT05384743UnknownPhase 3
Rituximab Monotherapy for Epstein-Barr Virus Associated Hemophagocytic Lymphohistiocytosis and Chronic Active Epstein-Barr Virus Infection With Only and Mainly B Lymphocytes of EBV Infection
Beijing Friendship Hospital1 site in 1 country30 target enrollmentStarted: February 1, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- EBV-DNA
Study Overview
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 B lymphocytes of EBV infection, to evaluate the clinical efficacy of Rituximab in the treatment of EBV-HLH and CAEBV.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Rituximab Monotherapy
Experimental
Intervention: Rituximab Monotherapy (Drug)
Outcomes
Primary Outcomes
EBV-DNA
Time Frame: Change from before and 2,4,6 and 8 weeks after initiating Rituximab monotherapy
Treatment effectiveness is defined: EBV-DNA copies/ml in peripheral blood turns negative, and the involved tissues (such as lymph nodes, bone marrow, skin, etc.) are negative in EBER test or the EBV copy number has decreased by more than 2 orders of magnitude, but it is still positive.
Secondary Outcomes
- Progression Free Survival(6 months)
- EBV-HLH Evaluation of treatment response(Change from before and 2,4,6 and 8 weeks after initiating Rituximab monotherapy)
- Adverse events(6 months)
Investigators
Zhao Wang
Clinical Professor
Beijing Friendship Hospital
Study Sites (1)
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