NCT01126892已完成3 期
An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.
研究概览
简要总结
A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.
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
- •Currently participating in Novartis study CAMN107A2109
- •Written signed and dated informed consent prior to any study procedures being performed
- •Male or female
- •> 18 years
- •ASL/ALT <= 2.5 ULN or <= 5.0 ULN
- •Alcaline Phosfatase <= 2.5 ULN
- •Serum Bilirrubin <= 1.5 ULN
- •Serum Creatinine <= 1.5 ULN or creatinine clearance >=50 ml/min / 24 hours
- •Serum Lipase <= 1.5 ULN
排除标准
- •Stratum 1 and stratum 2:
- •Reduction of the cardiac function
- •Use of Coumadin
- •Other severe medical concurrent conditions
- •Treatment with medications that prolonged the QT interval.
- •Mayor surgery 15 days before the inclusion in the protocol
- •Pregnant women or lactation
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Nilotinib
Experimental
干预措施: Nilotinib (Drug)
结局指标
主要结局
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.
时间窗: between 6 and 12 months
次要结局
- To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response(24 months)
- To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study(24 months)
- To follow loss of HR (after previous confirmed HR for AP and CHR for CP)(3, 6 and 12 months)
研究者
研究点 (2)
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