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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt

Conditions
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Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase

Intervention / Treatment
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* Drug: Imatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First cohort<br>Newly diagnosed patients | Drug: Imatinib<br>* Film coated tablet contains 400 mg imatinib (as mesilate)<br>* Other names: Carcemia®;|
| Second cohort<br>Patients switched from reference product (Glivec® ) | Drug: Imatinib<br>* Film coated tablet contains 400 mg imatinib (as mesilate)<br>* Other names: Carcemia®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 18 months | 
| Progression free survival (PFS) | Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint. | 18 months | 
| Event free survival (EFS) | Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint | 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. | 18 months | 
| Overall survival (OS) | Proportion of CML patients who will not die till 18 months study endpoint. | 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. | 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. | 12 months | 
| Health-Related Quality of Life (HRQoL) | Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits | 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. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imatinib, Generic Imatinib, Leukemia, Chronic myeloid leukemia, Philadelphia chromosome-positive, Chronic phase, Observational study, Switched patients, Tyrosine kinase inhibitor