A Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-cell Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 11
- 主要终点
- Infection Rate
研究概览
简要总结
The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.
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, and Rituximab
Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle)
干预措施: Rituximab (Drug)
Fludarabine, Cyclophosphamide, and Rituximab
Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle)
干预措施: Fludarabine (Drug)
Fludarabine, Cyclophosphamide, and Rituximab
Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle)
干预措施: Cyclophosphamide (Drug)
Pentostatin, Cyclophosphamide, and Rituximab
Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)
干预措施: Cyclophosphamide (Drug)
Pentostatin, Cyclophosphamide, and Rituximab
Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)
干预措施: Rituximab (Drug)
Pentostatin, Cyclophosphamide, and Rituximab
Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)
干预措施: Pentostatin (Drug)
结局指标
主要结局
Infection Rate
时间窗: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
infection=febrile events requiring treatment
次要结局
- Infective Event Rate(6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity)
- Percentage of Patients Hospitalized(6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity)
- Hematologic Recovery(2 months post-treatment)
- Mean Absolute Neutrophil Count (ANC) at Post-treatment(2 months post-treatment)
- Complete Remission (CR)(6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity)
- Objective Remission Rate (ORR)(6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity)
- Progression-free Survival (PFS) Rate at 1-year(12 months after registered.)
- Progression-free Survival (PFS) Rate at 2-year(24 months after registered.)