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
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.
Study Type
OBSERVATIONAL
Enrollment
173
Film coated tablet contains 400 mg imatinib (as mesilate)
National Cancer Institute (NCI)
Cairo, Egypt
Proportion of patients who achieve and maintain major molecular response (MMR)
Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%
Time frame: 12 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®)
Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
Time frame: 18 months
Progression free survival (PFS)
Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.
Time frame: 18 months
Event free survival (EFS)
Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint
Time frame: 18 months
Survival without blastic phase (BP)
Proportion of CML patients who will not experience blastic phase (BP) from enrollment to 18 months study endpoint.
Time frame: 18 months
Overall survival (OS)
Proportion of CML patients who will not die till 18 months study endpoint.
Time frame: 18 months
Complete cytogenetic response (CCgR)
Proportion of CML patients who will achieve no Ph+ metaphases at 12 months study endpoint by conventional cytogenetics and/or FISH test.
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Time frame: 12 months
Complete molecular response (CMR)
Proportion of CML patients who will achieve undetectable BCR-ABL mRNA transcripts by RQ-PCR test in two consecutive blood samples of adequate quality.
Time frame: 12 months
Health-Related Quality of Life (HRQoL)
Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits
Time frame: 18 months
Treatment compliance on generic Imatinib
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.
Time frame: 18 months