Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 13
- 主要终点
- the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
研究概览
简要总结
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.
详细描述
HBsAg Positive lymphoma patients are treated with entecavir when they receive rituximab-based immunochemotherapy. Entecavir 0.5mg daily is administrated from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment-naive patients with B-cell lymphoma
- •HBsAg positive at baseline
- •treated with rituximab-based immunochemotherapy
- •life expectancy of more than 3 months
排除标准
- •younger than 18 years old
- •HBsAg negative at baseline
- •pregnant or lactating women
研究组 & 干预措施
Entecavir prophylaxis
Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of immunochemotherapy and/or chemotherapy, and will be continued until 12 months after completion of the immunochemotherapy and/or chemotherapy.
干预措施: Entecavir prophylaxis (Drug)
结局指标
主要结局
the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
时间窗: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
次要结局
- the incidence of hepatitis B virus virological response(from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy)
- the incidence of hepatitis B virus serological response(from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy)
- the incidence of hepatitis B virus maintained response(from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy)
- the incidence of hepatitis B virus sustained response(from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy)
- the incidence of hepatitis B virus relapse and relapse related hepatitis(from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy)
研究者
Jun Zhu
Peking University Cancer Hospital & Institute
Peking University