试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 505
- 主要终点
- Percentage of Participants Who Were Alive and Free From Progressive Disease
研究概览
简要总结
It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.
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
- •Age over 18 years
- •Previously untreated, relapsed or refractory CD 20-positive FL
- •Responding to rituximab containing induction therapy (complete response [CR] or partial response [PR])
- •To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
- •No ineligibility for rituximab
排除标准
- •Not Applicable (NA)
研究组 & 干预措施
Relapsed/Refractory Stratum
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.
干预措施: Rituximab (Drug)
First-line Stratum
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.
干预措施: Rituximab (Drug)
结局指标
主要结局
Percentage of Participants Who Were Alive and Free From Progressive Disease
时间窗: 2 years
Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
次要结局
- Percentage of Participants Who Were Alive(2 years)
- Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy(2 years)
- Median Progression Free Survival (PFS) Time(2 years)
- Percentage of Participants With Best Overall Response(2 years)
- Median Overall Survival (OS) Time(2 years)
- Percentage of Participants With Initiation of New Therapy(2 years)