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.

• Imatinib (Drug), also known as Carcemia®: Film coated tablet contains 400 mg imatinib (as mesilate)

Primary outcomes

• Proportion of patients who achieve and maintain major molecular response (MMR) [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%

Secondary outcomes

• Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®) [18 months]: Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
• Progression free survival (PFS) [18 months]: Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.
• Event free survival (EFS) [18 months]: Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint
• Survival without blastic phase (BP) [18 months]: Proportion of CML patients who will not experience blastic phase (BP) from enrollment to 18 months study endpoint.
• Overall survival (OS) [18 months]: Proportion of CML patients who will not die till 18 months study endpoint.
• Complete cytogenetic response (CCgR) [12 months]: Proportion of CML patients who will achieve no Ph+ metaphases at 12 months study endpoint by conventional cytogenetics and/or FISH test.
• Complete molecular response (CMR) [12 months]: Proportion of CML patients who will achieve undetectable BCR-ABL mRNA transcripts by RQ-PCR test in two consecutive blood samples of adequate quality.
• Health-Related Quality of Life (HRQoL) [18 months]: Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits
• Treatment compliance on generic Imatinib [18 months]: Evaluated by identifying the frequency of not taking the medications as prescribed and the reasons. The decision on non-compliance is based on the treating physician's judgment.

Sex: All, ages: 18 Years to any

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