Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 817
- 试验地点
- 160
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fludarabine+Cyclophosphamide+Rituximab (FCR)
干预措施: Rituximab (Drug)
Fludarabine+Cyclophosphamide+Rituximab (FCR)
干预措施: Cyclophosphamide (Drug)
Fludarabine+Cyclophosphamide+Rituximab (FCR)
干预措施: Fludarabine Phosphate (Drug)
Fludarabine+Cyclophosphamide (FC)
干预措施: Cyclophosphamide (Drug)
Fludarabine+Cyclophosphamide (FC)
干预措施: Fludarabine Phosphate (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Median observation time at time of analysis was approximately 21 months
Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
Final Analysis: Time to Progression-free Survival Event
时间窗: Median observation time was approximately 66.4 months
Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
次要结局
- Event-free Survival (EFS)(Median observation time at time of analysis was approximately 21 months)
- Overall Survival (OS)(Median observation time at time of analysis was approximately 21 months)
- Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).(Median observation time at time of analysis was approximately 21 months)
- Final Analysis: Time to Overall Survival Event(Median observation time was approximately 66.4 months)
- Final Analysis: Time to Event-free Survival Event(Median observation time was approximately 66.4 months)
- Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)(Median observation time was approximately 66.4 months)
- Final Analysis: Duration of Response(Median observation time was approximately 66.4 months)
- Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response(Median observation time was approximately 66.4 months)
- Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)(Median observation time was approximately 66.4 months)