Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt

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.

Inclusion criteria

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

Exclusion criteria

• 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