Randomized Phase-III Trial Comparing Fludarabine and Cyclophosphamide Plus Rituximab (FCR) to FC and MabCampath (FCCam) for Previously Untreated Fit Patients With Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Progression-free survival at 36 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving fludarabine and cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works as first-line therapy compared with giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- To compare 36-month progression-free survival in patients with Binet stage B or C B-cell chronic lymphocytic leukemia treated with first-line therapy comprising fludarabine phosphate and cyclophosphamide and either rituximab or alemtuzumab.
Secondary
- To compare the disease-free survival, event-free survival, and overall survival of patients treated with these regimens.
- To compare time to next treatment in patients treated with these regimens.
- To compare the overall response rate (complete response [CR] and partial response [PR]) in patients treated with these regimens.
- To compare the rate of phenotypic and molecular response in patients treated with these regimens.
- To compare the duration of phenotypic, molecular, complete and partial responses in patients treated with these regimens.
- To compare the response rates and survival times in biological subgroups.
- To compare the rates of treatment-related adverse effects in patients treated with these regimens.
- To compare the quality of life of patients treated with these regimens.
- Minimal residual disease study.
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
FCCAM
Fludarabine-Cyclophosphamide-Campath (FCCam) Oral Fludarabine: 40 mg/m2 per os, D1 to D3 Oral Cyclophosphamide: 250 mg/m2/day as one dose at noon, D1 to D3 Campath®: 30 mg sc, D1 to D3 without dose escalation
干预措施: rituximab (Biological)
FCCAM
Fludarabine-Cyclophosphamide-Campath (FCCam) Oral Fludarabine: 40 mg/m2 per os, D1 to D3 Oral Cyclophosphamide: 250 mg/m2/day as one dose at noon, D1 to D3 Campath®: 30 mg sc, D1 to D3 without dose escalation
干预措施: cyclophosphamide (Drug)
FCCAM
Fludarabine-Cyclophosphamide-Campath (FCCam) Oral Fludarabine: 40 mg/m2 per os, D1 to D3 Oral Cyclophosphamide: 250 mg/m2/day as one dose at noon, D1 to D3 Campath®: 30 mg sc, D1 to D3 without dose escalation
干预措施: fludarabine (Drug)
FCR
Fludarabine-Cyclophosphamide-Rituximab (FCR)
First course:
Rituximab 375 mg/m2 on D1.
D2 to D4:
oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon
Subsequent courses (2 to 6)
Rituximab 500 mg/m2 on D1
D1 to D3:
oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon
干预措施: Campath (Biological)
FCR
Fludarabine-Cyclophosphamide-Rituximab (FCR)
First course:
Rituximab 375 mg/m2 on D1.
D2 to D4:
oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon
Subsequent courses (2 to 6)
Rituximab 500 mg/m2 on D1
D1 to D3:
oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
Progression-free survival at 36 months
时间窗: 36 months follow up
次要结局
- Disease-free survival(36 months follow up)
- Event-free survival(36 months follow up)
- Overall survival(36 months follow up)
- Time to next treatment(36 months follow up)
- Overall response rate (complete response [CR] and partial response [PR])(36 months follow up)
- Duration of phenotypic, molecular, NCI complete and partial responses(36 months follow up)
- Response rates and survival times in biological subgroups(36 months follow up)
- Treatment-related adverse effects(36 months follow up)