Radotinib Efficacy and Safety Validation in Chronic Phase Chronic Myeloid Leukemia Patients Who Are Intolerant or Resistant to at Least Two Tyrosine Kinase Inhibitors As a Third or Subsequent Line Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Rate of Major cytogenetic response
研究概览
简要总结
The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.
详细描述
The purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. The primary end point is major cytogenetic response by 12 months.
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
- •Chronic myeloid leukemia chronic phase (CP-CML) patients who are not tolerable or resistant to prior 2 or more tyrosine kinase inhibitors (TKIs).
- •ECOG 0, 1, 2
- •Patients who are agree and signed to informed consent.
排除标准
- •T315I mutation
- •Prior exposure to radotinib
- •Accelerated or blastic phase
- •galactose intolerance, severe lactase deficiency or glucose galactose malabsorption
- •Prior history of intensive cytotoxic chemotherapy except for TKIs
- •Significant cardiac problem
- •QTcF > 450 msec
- •Pancreatitis history prior to study enrollment
- •Clinically significant malignant disease other than CML
- •Pregnant or breast feeding woman
研究组 & 干预措施
Radotinib
Radotinib treatement single arm
干预措施: Radotinib (Drug)
结局指标
主要结局
Rate of Major cytogenetic response
时间窗: by 12 months after radotinib treatment
The rate of achieving major cytogenetic response \[35% or less t(9;22) chromosome by conventional banding technique\] in bone marrow by 12 months after radotinib treatment will be the primary end point.
次要结局
- Rate of Major Molecular response (MR3.0) on each time point(up to 12 months)
- The number of Participants with Adverse Events(12 months)
研究者
Hawk Kim
Associate Professor
Ulsan University Hospital