NCT00419250已完成1 期
A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 52
- 试验地点
- 35
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
- •ECOG < or = 2
- •Willing to agree to follow the pregnancy precautions.
排除标准
- •Pregnant or nursing women
- •Systemic treatment for B-cell CLL within 28 days of study start
- •Central nervous system involvement
- •History of renal failure requiring dialysis
- •Prior treatment with lenalidomide
- •Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
- •ANC < 1000 / ul
- •Platelet count < 50,000 / ul
- •Calculated creatinine clearance < 60 mL/min (Cockroft-Gault method)
- •AST or ALT > 3.0 x upper limit of normal
- •Serum total bilirubin > 2.0 mg/dl
- •Neuropathy > or = Grade 2
- •Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- •Richter's transformation (active)
研究组 & 干预措施
dose-escalation to 5 mg lenalidomide (len)
Experimental
escalate up to 5 mg once daily / 28-day cycle
干预措施: lenalidomide (Drug)
dose-escalation to 10 mg lenalidomide (len)
Experimental
escalate up to 10 mg once daily / 28-day cycle
干预措施: lenalidomide (Drug)
dose-escalation to 15 mg lenalidomide (len)
Experimental
escalate up to 15 mg once daily / 28-day cycle
干预措施: lenalidomide (Drug)
dose-escalation to 20 mg lenalidomide (len)
Experimental
escalate up to 20 mg once daily / 28-day cycle
干预措施: lenalidomide (Drug)
dose-escalation to 25 mg lenalidomide (len)
Experimental
escalate up to 25 mg once daily / 28-day cycle
干预措施: lenalidomide (Drug)
结局指标
主要结局
Safety
时间窗: February 2010
次要结局
- Absolute lymphocyte count(February 2010)
- Response(February 2010)
- Overall survival(February 2010)
- Duration of response(February 2010)
- Time to response(February 2010)
- Progression free survival(February 2010)
- Evaluation of minimal residual disease (MRD) by flow cytometry(February 2010)
研究者
研究点 (35)
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