NCT04591197招募中不适用
Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia : A Prospective, Multi-center, Single Arm Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MMR rates at 12 months
研究概览
简要总结
The overall survival (OS)of Chronic myeloid leukemia (CML) has been significantly improved since the advent of Tyrosine kinase inhibitors (TKIs) .Nevertheless, there still exists a amount of patients who has poor response or intolerance for TKI drugs( Imatinib, dasatinib, nilotinib). Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib,and it aslo has better security when compared to other TKIs(Imatinib, dasatinib, nilotinib).It will be a better chioce for CML patients.
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
- 是
入选标准
- •Age ≥ 18 years old, both male and female;
- •New Diagnosed Chronic Phase Chronic Myeloid Leukemia.
- •Within half a year after diagnosis of CML;
- •Previous TKIs treatment was less than 2 weeks;
- •The pregnant test of female patients was negative (within 7 days before medication before enrollment);
- •Informed consent of the patient or his legal representative
排除标准
- •T315I mutation is known to exist;
- •Rare atypical transcript types that cannot be standardized internationally;
- •Received TKI drugs for more than 2 weeks before enrollment;
- •Received interferon therapy for more than 3 months before enrollment;
- •Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation)
- •patients who participate in other clinical studies at the same time;
- •patients who having had major surgery or not recovered from surgery within 4 weeks;
- •patients who having history of malignant tumor
- •Woman who is pregnant or nursing
- •Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) > 3;
- •Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).
- •A clear history of neurological or psychiatric disorders, including epilepsy or dementia
结局指标
主要结局
MMR rates at 12 months
时间窗: 12 monts
MMR(BCR/ABL(IS)\<0.1%) at 12 months after treating
次要结局
- VEMR rates at 4 weeks(4 weeks)
研究者
xuna
Associate chief physician
Nanfang Hospital, Southern Medical University
研究点 (1)
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