Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia; a Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months
研究概览
简要总结
The purpose of this study is to evaluate Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
详细描述
This is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. In the study site, two cohorts will be identified among eligible patients, followed up, and assessed for a total of 12 months.
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
- •Age ≥18 years
- •Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
- •Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
- •Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range
- •Written informed consent
排除标准
- •CML in accelerated phase (AP) at enrolment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis
- •CML in BP at enrolment
- •Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics.
研究组 & 干预措施
Carcemia group
The cohort treated with Carcemia
干预措施: Carcemia (Drug)
Glivec Group
The cohort treated with Glivec
干预措施: Glivec (Drug)
结局指标
主要结局
Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months
时间窗: 12 months
Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months using RQ-PCR test (Appendix II) using Chi-square test. The MMR is defined as ration of BCR-ABL to ABL (or other housekeeping gene) ≤ 0.1% on the international scale (MMR is equal to a 3-log reduction in the ratio of BCR-ABL1: ABL from a standardized median baseline value).
次要结局
- Survival without blastic phase (BP) at 12 months(12 months)
- Complete cytogenetic response (CCyR) at 12 months(12 months)
- the safety & tolerability of imatinib after 12 months(12 months)
- Progression free survival (PFS) at 12 months(12 months)
- Event free survival (EFS) at 12 months(12 months)
- Overall survival (OS) at 12 months(12 months)
- Deep Molecular response (DMR) at 12 months(12 months)
- Treatment compliance(12 months)