NCT01340443已完成不适用
A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 24
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed CD20+ diffuse large B-cell lymphoma or follicular lymphoma
- •Treatment with MabThera/Rituxan as per locally approved China package insert
- •Documented patient with medical records
排除标准
- •Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 4.5 years
次要结局
- Overall Survival, defined as time from 1st treatment to death of any cause(4.5 years)
- Overall Response Rate (complete response + partial response)(4.5 years)
- Progression-free survival, defined as time from first treatment to lymphoma progression or death(4.5 years)
研究者
研究点 (24)
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