Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence rate of HBV reactivation
研究概览
简要总结
The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.
详细描述
In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated NHL suitable for CHOP/R-CHOP treatment
- •Age range 18-80 years old
- •HBsAg positive with high level of HBV DNA
- •Eastern Cooperative Oncology Group performance status 0-2
- •Life expectancy of more than 3 months
- •Adequate organ function
排除标准
- •Primary or secondary central nervous system involvement
- •With hepatitis C virus infection
- •Previous serious cardiac disease
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Pregnant or lactating women
- •Serious uncontrolled diseases and intercurrent infection
研究组 & 干预措施
entecavir
entecavir 0.5 mg/day PO
干预措施: Entecavir (Drug)
entecavir
entecavir 0.5 mg/day PO
干预措施: Lamivudine (Drug)
lamivudine
lamivudine 100 mg/day PO
干预措施: Entecavir (Drug)
lamivudine
lamivudine 100 mg/day PO
干预措施: Lamivudine (Drug)
结局指标
主要结局
Incidence rate of HBV reactivation
时间窗: 12 months
Defined by increased level of HBV DNA
次要结局
- Incidence rate and median time of treatment delay due to hepatitis(6 months)
- Incidence rate of hepatitis and HBV reactivation-related hepatitis(6 months)
- Incidence rate and median time of HBV DNA level normalization(6 months)