Evaluating Efficacy and Safety of Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia(CML-CP) : A Multicenter, Open-lable, Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 491
- 试验地点
- 1
- 主要终点
- Major molecular response rate at 12 months
研究概览
简要总结
The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). In ENESTnd and DASISION trials, both nilotinib and dasatinib achieved DMR more effectively than imatinib. In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China (2020 edition), flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients. There is no doubt that the second-generation TKIs show great advantages in deep molecular response, which further increases the possibility of achieving treatment-free remission. However, there is no direct comparative study to determine which TKI is better for de novo CML-CP. Thus, we conducted a multi-center, open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patients ≥18 years of age;
- •CML-CP patients diagnosed with CML within half a year；Patients who have been using second-generation TKI nilotinib or flumatinib for first-line treatment in clinical practice, but the history of continuous treatment does not exceed 3 months；3.patients are allowed to receive hydroxyurea treatment before first-line treatment with nilotinib or flumartinib; patients treated with interferon for no more than 3 months and other TKIs for no more than 2 weeks;
- •4.Patients who must sign informed consent before screening
排除标准
- •T315I mutation ; Y253F/H, E255K/V, F359C/V/I mutations in the nilotinib group;
- •Entry into another therapeutic clinical trial;
- •Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
- •History of neurological or psychiatric disorders, including epilepsy or dementia;
- •Major surgery within 4 weeks prior to Day 1 of study;
- •Patients with another primary malignancy,unless the other primary malignancy is currently stable or does not need active intervention;
- •Women of reproductive age or men who are unable to use adequate methods of contraception, including women who are pregnant or breastfeeding;
- •Patients who are unable to compliance with study or follow-up procedures;
研究组 & 干预措施
flumatinib
flumatinib 600mg QD, fasting administration
干预措施: Flumatinib Mesylate (Drug)
flumatinib
flumatinib 600mg QD, fasting administration
干预措施: Nilotinib Pill (Drug)
nilotinib
nilotinib 300mg BID, fasting administration
干预措施: Flumatinib Mesylate (Drug)
nilotinib
nilotinib 300mg BID, fasting administration
干预措施: Nilotinib Pill (Drug)
结局指标
主要结局
Major molecular response rate at 12 months
时间窗: 12 months
Major molecular response is defined as ≤ 0.1% BCR-ABL/ABL% by international scale
次要结局
未报告次要终点