NCT02511340Unknown2 期
Multi-center, Single Stage Phase II Study to Evaluate the Efficacy and Safety of Flumatinib in Accelerated or Blastic Phase Chronic Myelogenous Leukemia Patients
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Confirmed overall hematologic response（OHR）at 6 months
研究概览
简要总结
Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia patients.
详细描述
Multi-center, single-arm, open-label,phase II study to investigate efficacy and safety of Flumatinib in Chinese patients with accelerated or blastic Phase chronic myelogenous leukemia. The starting daily oral dose of Flumatinib is 600mg，core test is six cycles (each cycle is 28 days), collecting the core test data for primary efficacy analysis. The longest treatment time is 12 cycles.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients age 18-75 year-old;
- •ECOG 0 - 2;
- •Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase;
- •Adequate organ function;
- •Written informed consent prior to any study procedures being performed.
排除标准
- •Patients in Chronic and Blastic Phases;
- •Previously treated with Flumatinib;
- •Previously documented T315I mutations;
- •Previous therapy within protocol defined timeframe, including:
- •hydroxyurea within 24 hr,
- •Imatinib or Nilotinib or Dasatinib within 28 days)
- •Cardiac dysfunction ;
- •History of congenital or acquired bleeding disorders unrelated to CML;
- •Central nervous system leukemia;
- •Previous malignancy except CML;
- •Acute or chronic liver or severe kidney disease unrelated to CML;
- •Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.
研究组 & 干预措施
Flumatinib mesylate tablet 600 mg qd
Experimental
Flumatinib, 600mg, qd
干预措施: Flumatinib mesylate tablet 600 mg qd (Drug)
结局指标
主要结局
Confirmed overall hematologic response（OHR）at 6 months
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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