A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 32
- 主要终点
- Overall Complete Response (CR) Rate (Phase II)
研究概览
简要总结
This is a phase I - II multicenter, non-comparative, open label study in patients with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL).
详细描述
OBJECTIVES:
Primary
- To define the maximum tolerated dose (MTD) of Lenalidomide given in combination with FC.(Phase I)
- To evaluate the complete remission (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL). (Phase II)
Secondary
- To define the toxicity and the infection rate of patients treated with FCL and the median number of delivered courses of FCL, overall response rate and the progression-free survival and the relationship between the response and the baseline biologic factors (IgVH, FISH, ZAP-70, CD38).
- To evaluate the overall response rate (complete and partial responses).
- To evaluate the progression-free survival.
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
- 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
结局指标
主要结局
Overall Complete Response (CR) Rate (Phase II)
时间窗: After 6 months from study entry (end of treatment).
Response will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy, radiographic evaluation. Response will be evaluated at three different levels: clinical, cytometric and molecular.
Maximum Tolerated Dose of Lenalidomide (Phase I)
时间窗: The MTD of Lenalinomide will be evaluated during the two courses given with the escalated dose of Lenalinomide defined by the respective dose level.
Maximum tolerated dose of lenalidomide given in combination with fludarabine.
次要结局
- Number of Patients Reaching Disease-free Survival (DSF) Overall(After 6 months from study entry (end of treatment))
- Correlation Between Complete Response (CR) and Baseline Biologic Parameters (i.e., IgHV, CD38, Etc.).(After 6 months from study entry (end of treatment).)
- Toxicity as Assessed by NCI CTCAE v3.0(At 24 months from study entry (end of follow-up))
- Number of Patients With Severe Infections(At 24 months from study entry (end of follow-up))