Rituximab Monotherapy for EBV-HLH and CAEBV

Sponsor
Beijing Friendship Hospital
Study ID
NCT05384743
Phase
PHASE3
Status
Unknown

Conditions

  • Chronic Active Epstein-Barr Virus Infection
  • Secondary Hemophagocytic Lymphohistiocytosis

Eligibility Criteria

Sex
ALL
Age
2 Years - 80 Years
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
May 2022
Primary completion
Feb 1, 2024
Completion
Apr 1, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab Monotherapy

Primary Outcome Measure

EBV-DNA [ Time Frame: Change from before and 2,4,6 and 8 weeks after initiating Rituximab monotherapy ]

Central Contacts

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