An Open-label Phase II Study of the Efficacy and Safety of the Combination of Fludarabine, Cyclophosphamide and Rituximab in Patients With Chronic Lymphocytic Leukaemia Who Are Newly Diagnosed, Have Relapsed or Are Resistant to First-Line Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 7
- 主要终点
- Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis
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. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with cyclophosphamide and rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy, in terms of complete remission rate, of fludarabine phosphate, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia.
Secondary
- Determine the time to treatment failure (TTF) in these patients.
- Determine the overall survival of these patients until 10th January 2019.
- Assess the predictive value of immunophenotype, hypermutation analysis, and FISH in determining TTF and OS in these patients.
- Determine the safety profile of this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 64 Years（Child, 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, Cylophosphamide and Rituximab
干预措施: pegfilgrastim (Biological)
Fludarabine, Cylophosphamide and Rituximab
干预措施: rituximab (Biological)
Fludarabine, Cylophosphamide and Rituximab
干预措施: cyclophosphamide (Drug)
Fludarabine, Cylophosphamide and Rituximab
干预措施: fludarabine phosphate (Drug)
Fludarabine, Cylophosphamide and Rituximab
干预措施: cytogenetic analysis (Genetic)
Fludarabine, Cylophosphamide and Rituximab
干预措施: fluorescence in situ hybridization (Genetic)
Fludarabine, Cylophosphamide and Rituximab
干预措施: gene expression analysis (Genetic)
Fludarabine, Cylophosphamide and Rituximab
干预措施: mutation analysis (Genetic)
Fludarabine, Cylophosphamide and Rituximab
干预措施: protein expression analysis (Genetic)
Fludarabine, Cylophosphamide and Rituximab
干预措施: flow cytometry (Other)
Fludarabine, Cylophosphamide and Rituximab
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis
时间窗: A formal assessment of response by NCI Criteria (Appendix 3) with the addition of assessment of minimal residual disease in the marrow and if relevant assessment of bulky disease by CT scanning will be made after 4 +/-6 courses of therapy.
次要结局
- Overall survival(Until 10th January 2019)
- Time to treatment failure (TFF)(A clinical assessment of response will be made after 4 courses of therapy, Patients with evidence of progressive disease will stop therapy and will be deemed to have failed treatment.)
- Acute and chronic toxicity as assessed by NCI criteria(A formal assessment of response by NCI Criteria (Appendix 3) with the addition of assessment of minimal residual disease in the marrow and if relevant assessment of bulky disease by CT scanning will be made after 4 +/-6 courses of therapy.)
- Predictive value of immunophenotype, FISH, and hypermutation analysis in determining TTF and OS(See description)