JPRN-UMIN000003016已完成2 期
Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant. - Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant.
Osaka CML-MRD Meeting0 个研究点目标入组 45 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1) accelerating phase(AP) patients with following one or more condition or suspected blast phase (BC) patients AP: -blast rate >= 15% in peripheral blood or bone marrow, and < 30% in both peripheral blood and bone marrow -blast + promyelocyte : >= 30% in peripheral blood or bone marrow -basophil rate: >= 20% in peripheral blood -platelet: continuous decline on treatment independently (<= 10,000 / cubic millimeter) BC: -blast: >= 30% in peripheral blood or bone marrow -No blast increase extramedullary except hepatosplenomegaly proven by biopsy 2) No drug history of Hydrea or IFN-alpha as CML treatment 3) Class 3, 4 in NYHA 4) Double invasive cancer within 5 years before beginning of otinib 5) Uncontrollable disease complication 6) Diagnosed HIV 7) patients during pregnancy or possible in pregnancy 8) Patients during lactation or expecting pregnancytients 9) Patients with psychiatric disease or psychological symptom
研究者
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