Rituximab Monotherapy for EBV-HLH and CAEBV

NCT ID: NCT05384743

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-04-01

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.

Conditions

Secondary Hemophagocytic Lymphohistiocytosis; Chronic Active Epstein-Barr Virus Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab Monotherapy

Group Type: EXPERIMENTAL

Rituximab Monotherapy

Intervention Type: DRUG

Rituximab 375mg/m2. This regimen was repeated after 1 week. A total of 2-4 courses of treatment.（After two courses of treatment, EBV-DNA turned negative, no need to apply again. If EBV-DNA is still positive after two courses of treatment, 2 courses of treatment are applied again).

Interventions

Rituximab Monotherapy

Rituximab 375mg/m2. This regimen was repeated after 1 week. A total of 2-4 courses of treatment.（After two courses of treatment, EBV-DNA turned negative, no need to apply again. If EBV-DNA is still positive after two courses of treatment, 2 courses of treatment are applied again).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhao Wang

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhao Wang

Role: CONTACT

zhaowww263@yahoo.com

86-010-63139862

Facility Contacts

Zhao Wang

Role: primary

zhaowww263@yahoo.com

Other Identifiers

Rituximab;CAEBV;EBV-HLH

Identifier Type: -

Identifier Source: org_study_id