A Comparative Study of the Efficacy and Safety of Entecavir and Tenofovir Versus Entecavir Alone in the Treatment of Hepatitis B DNA-positive Patients With Lymphomas
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The rate of successful HBV replication inhibition at cycle 2
研究概览
简要总结
This is a prospective, single-center, open-label, randomized controlled trial aimed to evaluate the efficacy and safety of entecavir and tenofovir versus entecavir alone in the antiviral treatment of HBV DNA positive B-cell lymphoma patients.
This study plans to enroll about 120 participants in total. Recruitment will last for 2 years.
The study visit will take place on the first day of each cycle of therapy until the end of the treatment.
Participants who meet the inclusion/exclusion criteria were randomly assigned to receive entecavir and tenofovir or entecavir alone after signing the informed consent. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. When the copy count of HBV DNA drops below 1*10^3/L, entecavir single agent will be given orally, until one year after the cycle of therapy.
Treatment response will be evaluated routinely after chemotherapy or immunotherapy.
Within 2 years after the last participant is enrolled, participants' survival information will collected by telephone and/or clinical visit every 3 months after the last visit (i.e. date and cause of death, subsequent cancer treatment, etc.), if there is no withdrawal of the informed consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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, pathologically confirmed diagnosis of B-cell lymphomas with the viral load of HBV DNA>1*10^3/L
- •Age≥18 years old
- •Measurable lesions in radiographic images, defined as at least one well-defined lesions/knots, with both the long diameter and the short diameter≥1.5cm
- •Life expectancy of at least 3 months according to researchers' judgement
- •Written informed consent must be provided by participants or their legal representatives prior to any research examination or procedure
排除标准
- •Creatine<50mL/min
- •Any medical condition that may affect the conduction of this study according to researchers' judgement
研究组 & 干预措施
Entecavir and Tenofovir
干预措施: Tenofovir (Drug)
Entecavir and Tenofovir
干预措施: Entecavir (Drug)
Entecavir
干预措施: Entecavir (Drug)
结局指标
主要结局
The rate of successful HBV replication inhibition at cycle 2
时间窗: At the start of cycle 2 (each cycle is 21-28 days)
The rate of participants that the copy count of HBV DNA is lower than 1\*10\^3/L.
次要结局
- Time to successful HBV replication inhibition(During the intervention)
- 2-year PFS(2 years after enrollment)
- 2-year OS(2 years after enrollment)
- Complete response rate(After the completion of first-line chemotherapy, an average of 4 months from enrollment)
- The incidence of adverse events(From enrollment to study completion, an maximum of 3 years.)
研究者
Zhao Weili
First Deputy Director of Shanghai Institute of Hematology
Ruijin Hospital