Efficacy and Safety of Ruxolitinib single treatment in patients with chronic active Epstein-Barr virus infection (Phase II) (investigator-initiated study) - Efficacy and Safety of Ruxolitinib for CAEBV patients (Phase II)

St. Marianna University School of Medicine0 个研究点目标入组 9 人开始时间: 2018年12月15日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: St. Marianna University School of Medicine
入组人数: 9

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 13years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•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.

研究者

发起方

St. Marianna University School of Medicine

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