NCT01210287Unknown2 期
Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- incidence of HBV reactivation
研究概览
简要总结
The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naive DLBCL or high grade FL patients
- •Age range 18-75 years old
- •ECOG performance status 0-3
- •Life expectancy of more than 3 months
- •Adequate organ function
- •HBsAg negative/HBcAb positive at baseline
排除标准
- •Infection of HAV,HCV,HIV
- •Pregnant or lactating women
- •Serious uncontrolled diseases
研究组 & 干预措施
Observation
No Intervention
Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.
干预措施: nucleoside analog reverse transcriptase inhibitor (Drug)
结局指标
主要结局
incidence of HBV reactivation
时间窗: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP
HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).
次要结局
- the outcome of antiviral therapy in HBV-DNA abnormal patients(from the initiation of antiviral thearpy to six months after the last cycle of RCHOP)
研究者
Junning Cao
Vice Director of the department of Medical Oncology, Fudan University Cancer Center
Fudan University
研究点 (2)
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终止
2 期
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