Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.
详细描述
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 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
- •Age ≥ 18 years.
- •Diagnosis of CML-CP with Ph+.
- •ECOG performance of 0-
- •Adequate end organ function defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
- •Treatment failure after imatinib at 3 or 6 months with BCR-ABL >10%.
- •Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
排除标准
- •Previously documented T315I mutation.
- •History of TKI treatments except of imatinib.
- •History of undergone major surgery within 4 weeks.
- •Patients unwilling or unable to comply with the protocol.
- •Pregnant or breast-feeding patients.
- •patients with other malignant tumor.
研究组 & 干预措施
Flumatinib
干预措施: Flumatinib (Drug)
结局指标
主要结局
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.
时间窗: 12 months
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
次要结局
- Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.(3, 6, 9, 12 months.)
- Proportion of patients with MMR at 3, 6, 9 months.(3, 6, 9 months)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib.(24 months)
- Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.(3, 6, 9, 12 months.)