NCT00147901已完成2 期
Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination With Alemtuzumab (FC-Cam) for Patients With Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Overall response rate (complete and partial response rate)
研究概览
简要总结
This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.
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
- •B-CLL in need of treatment
- •One or two prior prior therapies
- •WHO performance status 0-2
排除标准
- •Serum creatinine > 1.5 ULN
- •Major organ dysfunctions
- •Pregnant or nursing
研究组 & 干预措施
FCCam
Experimental
After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
干预措施: FCCam (Drug)
结局指标
主要结局
Overall response rate (complete and partial response rate)
时间窗: 28 days after the end of the last cycle
Response Evaluation has to be done according the the NCI guidelines
次要结局
- Toxicity(28 days following the last dose of FCCam)
- MRD response rate(28 days after the end of the last cycle)
- Response rate in biological defined risk groups(28 days after the end of the last cycle)
- Duration of response(up to 36 months after the end of treatment)
- Treatment administration (dose intensity)(up to the last day of the last given cycle (day 28 of the 6th cycle))
- Overall survival(up to 36 months after the end of treatment)
研究者
研究点 (1)
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