Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 825
- 试验地点
- 87
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. 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. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is more effective than observation alone in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and cyclophosphamide to see how well they work compared to observation alone in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Compare the effect, in terms of event-free survival, of deferred versus immediate treatment with rituximab, fludarabine, and cyclophosphamide in patients with previously untreated Binet stage A chronic lymphocytic leukemia at high risk for disease progression.
- Investigate and define a new prognostic staging system for patients with Binet stage A chronic lymphocytic leukemia.
Secondary
- Compare the time to progression to Binet stages B and C in patients treated with these regimens.
- Compare the overall and progression-free survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the time to treatment in patients treated with these regimens.
- Analyze the pharmacoeconomics of these regimens in these patients.
- Determine the overall response rate (partial and complete) in patients included in the early treatment arm.
- For patients included in the early treatment arm in complete remission, determine the percentage achieving complete molecular remission using the clone-specific CDR-III region as follow-up parameter.
- Determine the duration of response in patients included in the early treatment arm.
- Determine any adverse events related to treatment/safety of treatment.
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
Cohort I (FCR)
Patients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort I receive Fludarabine, Cyclophosphamide and Rituximab (FCR) chemoimmunotherapy.
干预措施: Fludarabine (Drug)
Cohort I (FCR)
Patients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort I receive Fludarabine, Cyclophosphamide and Rituximab (FCR) chemoimmunotherapy.
干预措施: Cyclophosphamide (Drug)
Cohort I (FCR)
Patients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort I receive Fludarabine, Cyclophosphamide and Rituximab (FCR) chemoimmunotherapy.
干预措施: Rituximab (Biological)
结局指标
主要结局
Event-free survival
Development of a new prognostic staging system
次要结局
- Progression free survival
- Time to treatment
- Quality of life
- Overall response (complete and partial) rate in patients in the early treatment arm
- Overall survival
- Adverse events in patients in the early treatment arm
- Time to progression to Binet stages B and C
- Pharmacoeconomic analysis
- Percentage of patients achieving complete molecular remission in the early treatment arm
- Duration of response in patients in the early treatment arm