NCT00413270No Longer Available不适用
A Canadian Open-label, Multicenter, Expanded Access Study of Oral Nilotinib in Adult Patients With Imatinib-resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.
研究设计
- 研究类型
- Expanded Access
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
- •Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis
- •Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase
- •Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase
- •CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance
- •World Health Organization (WHO) performance status ≤ 2
排除标准
- •Cytopathologically confirmed central nervous system (CNS) infiltration
- •Impaired cardiac function
- •Use of therapeutic coumarin derivatives
- •Acute chronic liver or renal disease unrelated to tumor
- •Other uncontrolled medical conditions
- •Treatment with hematopoeitic colony stimulating factors
- •Treatment with medications that have potential to prolong the QT interval
- •Another malignancy currently clinically significant or requires active intervention
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
研究点 (1)
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