An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy With Tenofovir in HBsAg-positive Patients With Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Percentage number of patients with hepatitis due to HBV reactivation
研究概览
简要总结
An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED study)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged more than18
- •HBsAg-positive DLBCL patients (it is possible to enrol the patients with combined DLBCL and low grade lymphoma such as follicular lymphoma)
- •Previously untreated DLBCL patients who are suitable for receiving R-CHOP chemotherapy
- •Serum ALT no more than 2 x ULN (including normal ALT)
- •Life expectancy 6 months
- •A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are no more than 1 years after the onset of menopause.
- •Informed consent
排除标准
- •Other subtype of lymphoma except DLBCL
- •DLBCL patients who are NOT suitable for receiving R-CHOP chemotherapy OR plan to receive other chemotherapy
- •patients had been treated with antiviral therapy known to have activity against HBV (e.g., alpha-interferon, lamivudine, telbivudine, clevudine, adefovir, entecavir or tenofovir) within the previous 6 months.
- •evidence of hepatocellular carcinoma.
- •evidence of decompensated liver disease
结局指标
主要结局
Percentage number of patients with hepatitis due to HBV reactivation
时间窗: 2 years (every 3 months)
Percentage number of patients with hepatitis due to HBV reactivation during the preemptive tenofovir therapy and for 24 weeks after withdrawal from tenofovir. Definition; * Hepatitis was defined as a more than 3-fold increase of serum ALT on 2 consecutive determinations at least 5 days apart. * Hepatitis was defined to be due to HBV reactivation when it was preceded or accompanied by an increase of serum HBV DNA to more than 10 times that of the pre-exacerbation baseline and the serum HBV DNA turned from negative to positive.
Percentage number of patients with hepatitis due to Safety assessment
时间窗: 2 years (every 3 months)
Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance
Chemotherapy disruption due to hepatitis
时间窗: 2 years (every 3 months)
Chemotherapy disruption due to hepatitis: defined as either premature termination or delay of more than 8 days between chemotherapy cycles.
次要结局
未报告次要终点