Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 133
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide.
Secondary
- Compare the incidence of side effects and quality of life of patients treated with these drugs.
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 65 Years（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 plus Cyclophosphamide
干预措施: Fludarabine plus Cyclophosphamide (Drug)
Fludarabine
干预措施: Fludarabine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 18 Month after end of treatment of the last patient
date of randomization until progression of disease or death of any cause
Overall survival
时间窗: 18 Month after end of treatment of the last patient
Date of randomization until date of death
Duration of remission
时间窗: 18 Month after end of treatment of the last patient
Clinical response was defined according to the guidelines of the NCI-sponsored workshop
次要结局
- Incidence of side effects(up to 28 days after the last dose of study medication)
- Quality of life(18 Month after end of treatment of the last patient)