NCT04925141已完成4 期
Efficacy and Safety of Dasatinib in the First-line Treatment of Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Proportion of subjects who achieve and maintain major molecular response (MMR) at 12 months
研究概览
简要总结
The purpose of this multicenter,open, prospective and single arm study is to evaluate the efficacy and safety of domestic dasatinib in the first-line treatment of newly diagnosed CML-CP.
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
- •Aged ≥ 18 years and gender is not limited.
- •The chronic-phased CML subjects with Ph + were definitely diagnosed within 6 months before the first use of the study drug. The diagnostic criteria refer to the 2016 edition of Chinese CML diagnosis and treatment guidelines.
- •The Eastern Cooperative Oncology Group (ECOG) performance of 0-
- •The function of main organs such as liver and kidney is normal, which shows that serum bilirubin is less than or equal to 1.5 × ULN； Serum ALT and AST ≤ 2.5 × ULN； Serum Cr ≤ 1.5 × ULN； Serum amylase and lipase ≤ 1.5 × ULN; Blood potassium, magnesium, phosphorus and total calcium were more than or equal to the lower limit of normal value, or were corrected to normal range before administration.
- •The subjects voluntarily participate in and signed the informed consent form (ICF), and the process of signing the ICF meet the requirements of the "Practice for quality management of drug clinical trials".
排除标准
- •Subjects who have received any TKI treatment in the past.
- •Subjects who have received or are receiving anti CML chemotherapy drugs (except hydroxyurea).
- •Subjects who have received major surgery or no recovery from previous surgery within 4 weeks (including 4 weeks) before the first use of the study drug.
- •Subjects with mental illness, including epilepsy, dementia, severe depression, mania, etc.
- •Subjects with a history of significant congenital or acquired hemorrhagic disease unrelated to CML.
- •Disease history and comorbidities: a) uncontrolled severe disease or active infection that impairs the subject's ability to receive the treatment; b) Uncontrolled or major cardiovascular disease; c) Pulmonary hypertension; d) Subjects with pleural effusion or pericardial effusion of any grade are excluded when screening; when entering the study, subjects with remission of pleural / pericardial effusion of any grade previously diagnosed were allowed to participate in the study.
- •Subjects with gastrointestinal dysfunction or gastrointestinal diseases that may significantly affect the absorption of the test drug, such as ulcers, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, after a small bowel resection, etc.
- •Cardiac dysfunction, including: a) complete left bundle branch block; b) Long QT syndrome, or known family history of long QT syndrome; c) Ventricular or atrial tachyarrhythmia of clinical significance; d) Clinically significant resting bradycardia (< 50 beats per minute); e) QTc>450msec； f) History of clinically confirmed myocardial infarction in the past 12 months; g) History of unstable angina in the past 12 months; h) Other clinicallysignificant heart diseases (e.g., congestive heart failure, etc.).
- •Combined with other primary malignant tumors (except basal cell carcinoma of skin).
- •Subjects who are receiving treatment with strong CYP3A4 inhibitors (e.g., erythromycin Ethylsuccinate, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, imipradil, etc.) and cannot discontinue or switch to other drugs before starting the study drug.
- •Subjects who are receiving strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, Hypericum perforatum, etc.) and the treatment cannot be stopped or replaced by other drugs before starting the study drug.
- •Subjectswho are receiving the treatment of drugs that may prolong QT interval, and the treatment can not be stopped or replaced by other drugs before starting to use the study drug.
- •Previous history of acute (within 1 year before inclusion) or chronic pancreatitis.
- •Known or suspected to be allergic to this kind of drug.
- •Female and male subjects of childbearing age who cannot use adequate methods of contraception , including pregnant or lactating women.
- •Subjects who are receiving the treatment of other test drugs or participated in the clinical trial of other drugs within one month.
研究组 & 干预措施
Dasatinib tablets
Experimental
Dasatinib tablets 100 mg orally once daily
干预措施: Dasatinib Tablets (Drug)
结局指标
主要结局
Proportion of subjects who achieve and maintain major molecular response (MMR) at 12 months
时间窗: up to 12 months
MMR is defined as BCR-ABL1IS ≤ 0.1%
次要结局
- Cumulative complete cytogenic response (CCyR) rates at 12 and 24 months(up to 24 months)
- Proportion of subjects who achieve and maintain MMR at 3，6 and 18 months(up to 18 months)
- Time to MMR Overall(up to 24 months)
- Proportion of subjects who achieve and maintain complete hematological response (CHR) at 3 months(up to 3 months)
- Cumulative MMR rates at 6, 12 and 24 months(up to 24 months)
- Proportion of subjects who achieve and maintain MR4.0 and MR4.5 at 6, 12 and 24 months(up to 24 months)
- Event free survival (EFS)(up to 24 months)
- ABL mutation rate after 6 months of treatment(up to 6 months)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib(up to 24 months)
- Progression-free Survival (PFS)(up to 24 months)
- Time to accelerated phase (AP ) / blast crisis (BC)(up to 24 months)
研究者
研究点 (4)
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