NCT00262795已完成3 期
Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 88
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, 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 fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.
- Compare the duration of remission in patients treated with these regimens.
Secondary
- Compare the incidence of toxicity, especially infections, in patients treated with these regimens.
- Compare the quality of life in patients treated with these regimens.
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
- 65 Years 至 79 Years（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
CLB
Active Comparator
Chlorambucil
干预措施: Chlorambucil (Drug)
F
Experimental
Fludarabine
干预措施: Fludarabine (Drug)
研究者
研究点 (88)
Loading locations...
相似试验
已完成
3 期
Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic LymphomaLymphomaNCT00608374Taunton and Somerset Hospital400
已完成
3 期
Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT00276848German CLL Study Group375
已完成
3 期
Fludarabine, Cyclophosphamide, and Rituximab or Alemtuzumab in Treating CLL2007 CLL 2007 FMPLeukemiaNCT00564512French Innovative Leukemia Organisation178
Unknown
2 期
Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell LymphomaLymphomaNCT00958854Cancer Research UK37
已完成
1 期
Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic LeukemiaLeukemiaNCT00096018Roswell Park Cancer Institute43