Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve and maintain major molecular response (MMR)
研究概览
简要总结
The purpose of this observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in Egypt
详细描述
An observational, multi-center, prospective cohort study to assess the effectiveness and safety of generic Imatinib (Carcemia®) in patients with Ph+ CML who are newly diagnosed or patients who will be switched from the reference product (Glivec® ) to Carcemia® where treatment will be prescribed by the investigator in accordance with clinical practice where no visits or intervention(s) additional to the daily practice will be performed.
Eligible Ph+ CML patients in both cohorts will be followed up for a total of 18 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
- •First cohort (newly diagnosed patients):
- •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
- •Second cohort (switched patients):
- •Age ≥18 years
- •Ph+ CML patients in CP currently treated with Glivec®, with or without the presence of other cytogenetic abnormalities at the time of switch
- •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 enrollment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis
- •CML in BP at enrollment
- •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
Second cohort
Patients switched from reference product (Glivec® )
干预措施: Imatinib (Drug)
First cohort
Newly diagnosed patients
干预措施: Imatinib (Drug)
结局指标
主要结局
Proportion of patients who achieve and maintain major molecular response (MMR)
时间窗: 12 months
Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%
次要结局
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®)(18 months)
- Progression free survival (PFS)(18 months)
- Event free survival (EFS)(18 months)
- Survival without blastic phase (BP)(18 months)
- Overall survival (OS)(18 months)
- Complete cytogenetic response (CCgR)(12 months)
- Complete molecular response (CMR)(12 months)
- Health-Related Quality of Life (HRQoL)(18 months)
- Treatment compliance on generic Imatinib(18 months)