Rituximab Monotherapy for EBV-HLH and CAEBV

NCT05384743 | Unknown Phase 3

• 1 other identifier: Rituximab;CAEBV;EBV-HLH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• EBV-DNA

  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.

  Change from before and 2,4,6 and 8 weeks after initiating Rituximab monotherapy

Secondary Outcomes (3)

• EBV-HLH Evaluation of treatment response

  Change from before and 2,4,6 and 8 weeks after initiating Rituximab monotherapy

• Progression Free Survival

  6 months

• Adverse events

  6 months

Study Arms (1)

Rituximab Monotherapy

EXPERIMENTAL

Drug: Rituximab Monotherapy

Interventions

Rituximab Monotherapy 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).

Rituximab Monotherapy

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Zhao Wang

Beijing, China

RECRUITING

Central Study Contacts

Zhao Wang

CONTACT

86-010-63139862; zhaowww263@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: May 20, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

CN (1)