NCT02204644已完成3 期
Randomized, Multi-center, Open-label Phase III Study of the Efficacy and Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- SIX-month major molecular response rate
研究概览
简要总结
A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.
Randomized,Open Label,Control
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Men and women aged 18-75 year-old
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- •Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis
- •Adequate organ function
排除标准
- •received TKIs drug treatment before enrollment
- •Central nervous system leukemia
- •Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation)
- •Cardiac dysfunction
- •Previous splenectomy
- •History of congenital or acquired bleeding disorders unrelated to CML
- •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 tablets
Experimental
Flumatinib mesylate tablets 600mg qd for 12 months
干预措施: Flumatinib 600mg qd (Drug)
Imatinib mesylate tablets
Active Comparator
Imatinib mesylate tablets 400mg qd for 12months
干预措施: Imatinib 400mg qd (Drug)
结局指标
主要结局
SIX-month major molecular response rate
时间窗: six months
次要结局
- major molecular response rate(3 months, 9 months and 12 months)
研究者
研究点 (1)
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