Efficacy and Safety of Ruxolitinib single treatment in patients with chronic active Epstein-Barr virus infection (Phase II) (investigator-initiated study)
- Conditions
- chronic active Epstein-Barr virus infection CAEBV
- Registration Number
- JPRN-UMIN000035121
- Lead Sponsor
- St. Marianna University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
Subjects matched any of the followings are excluded; (1) pathological or clinical lymphoid neoplasm derived from EBV-infected T- or NK-cells of CAEBV. (2) anti-VCA-IgM Ab positive (difficult to distinguish from infectious mononucleosis). (3) with history taking JAK 1/2 inhibitors. (4) with malignant neoplasm or history of them within the last 5 years, though cervical intraepithelial carcinoma, basal cell carcinoma or squamous cell carcinoma of the skin treated properly, fully resected gastric intramucosal carcinoma can be accepted. (5) with unstoppable treatment with >200 mg/day fluconazole or strong CYP3A4 inducer (rifampicin, St. John's wart etc) at the beginning of study drug administration (excl. topical). (6) with infectious diseases requiring systemic antibiotics or antivirals. (7) with tuberculosis or HIV-positive. (8) with active hepatitis matching any of the following within 84 days before registration; -HBs Ag-positive -HBc Ab-positive or HBs Ab-positive with >= 20 IU/mL (1.3 Log IU/mL, the same below) of peripheral blood HBV DNA load HBs Ag-negative, HBs Ab-positive, HBc Ab-negative and history of the vaccination for HBV are treated as uninfected ones. -HCV Ab-positive (except when confirmed HCV-RNA-negative). * There are some conditions for judgment of HBV infection. (9) with cardiac disease of NYHA class IV. (10) having been treated with other anticancer drug (e.g. etoposide) within 14 days prior to registration. (11) with history of hypersensitivity to ingredients of ruxolitinib tablet. (12) having been treated with another investigational medication within 12 weeks prior to registration. (13) female who are pregnant, have possibility of pregnancy, or are currently breastfeeding. (14) difficult to take oral tablet. (15) judged unsuitable for participation by investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with complete response (CR) at week 8 or early termination.
- Secondary Outcome Measures
Name Time Method Percentage of participants with complete response (CR) at week 4. Overall response rate at week 8 or early termination. Adverse event. Plasma drug concentration. Epstein-Barr virus DNA quantification . Plasma cytokine concentration.