Subcutaneous MabCampath® (Alemtuzumab) and Oral Fludara® (Fludarabinephosphate) for the Treatment of Refractory or Relapsed Chronic Lymphocytic Leukemia in 2nd or 3rd Line of Treatment: A Pilot Trial (FLUSALEM) for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Safety and tolerability
研究概览
简要总结
Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4 cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary treatment or with disease refractory to any therapy in 1st or 2nd line (including Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of alemtuzumab s.c.
After the first phase (completed treatment of 7 patients) an interim analysis of safety and efficacy will be performed. In case of a sufficient risk benefit assessment followed by the enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be based on all patients enrolled.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with CD23+, CD5+, CD19+, light chain monoclonal B CLL
- •1st or 2nd relapse after fludarabine or any other primary treatment regimen or refractory to primary or secondary treatment (including fludarabine) and simultaneously indication for treatment according to the NCI Workshop Criteria 1996
- •Age 19-75
- •WHO performance score 0-2
- •Informed consent given by the patient
排除标准
- •HIV positive or positive for Hepatitis B or C
- •active uncontrolled infection
- •child bearing age without adequate control of fertility, pregnant or lactating women
- •intolerance towards any ingredient of either oral fludarabine or alemtuzumab
- •allergy against foreign proteins
- •previous treatment with alemtuzumab
- •treatment with an experimental drug within the previous 2 months
- •second malignant disease (non CLL)
- •CLL in transformation (Richter syndrome)
- •decreased kidney-function with creatinine-clearance < 30ml/min
- •severe concomitant diseases or major organ dysfunctions
- •patients who are unable to comply with the requirements of the protocol
研究组 & 干预措施
Overall study
The FLUSALEM protocol combines 4 cycles of oral fludarabine phosphate (40mg/m² d1-3; q 29d) and an intensive dose schedule of alemtuzumab (30mg sc.3 times weekly for 16 weeks) in an outpatient setting
干预措施: Fludarabine phosphate (Drug)
Overall study
The FLUSALEM protocol combines 4 cycles of oral fludarabine phosphate (40mg/m² d1-3; q 29d) and an intensive dose schedule of alemtuzumab (30mg sc.3 times weekly for 16 weeks) in an outpatient setting
干预措施: Alemtuzumab (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: within the duration of study
Complete and overall response rate
时间窗: within the duration of study
Infections grade III, IV
时间窗: within the duration of study
Rate of CMV reactivation
时间窗: within the duration of study
次要结局
- Time to retreatment(within duration of trial)
- Response in lymphatic compartments(within duration of trial)
- Overall survival(within duration of trial)
- Molecular response/ immunologic MRD response(within duration of trial)
- Quality of Life(within duration of trial)