Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

Detailed Description
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This is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. In the study site, two cohorts will be identified among eligible patients, followed up, and assessed for a total of 12 months.

Official Title
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Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia; a Multicenter, Observational Study

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: Carcemia
* Drug: Glivec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. CML in accelerated phase (AP) at enrolment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis 2. CML in BP at enrolment 3. 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 |
| --- | --- |
| Carcemia group<br>The cohort treated with Carcemia | Drug: Carcemia<br>* Generic Imatinib<br>|
| Glivec Group<br>The cohort treated with Glivec | Drug: Glivec<br>* Imatinib<br>|

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) at 12 months | Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months using RQ-PCR test (Appendix II) using Chi-square test. The MMR is defined as ration of BCR-ABL to ABL (or other housekeeping gene) ≤ 0.1% on the international scale (MMR is equal to a 3-log reduction in the ratio of BCR-ABL1: ABL from a standardized median baseline value). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the safety & tolerability of imatinib after 12 months | In both cohorts, the safety & tolerability of imatinib after 12 months of treatment will be assessed by: The number, type, severity and frequency of the adverse reactions particularly those described in the SmPC of the reference product. Incidence of adverse events (AEs) & serious adverse events (SAEs). AEs leading to permanent treatment discontinuation. Clinically relevant changes in laboratory tests (according to laboratory reference ranges). | 12 months | 
| Progression free survival (PFS) at 12 months |  | 12 months | 
| Event free survival (EFS) at 12 months |  | 12 months | 
| Survival without blastic phase (BP) at 12 months |  | 12 months | 
| Overall survival (OS) at 12 months |  | 12 months | 
| Complete cytogenetic response (CCyR) at 12 months |  | 12 months | 
| Deep Molecular response (DMR) at 12 months |  | 12 months | 
| Treatment compliance | Treatment compliance while on imatinib will be evaluated by identifying the frequency of not taking the medications as prescribed and the reason behind that based on the prescription pattern. The decision on non-compliance is based on the treating physician's judgment. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imatinib, Carcemia, Leukemia, Cohort study, Effectiveness, Safety, Observational study, Cancer, Blood cancer, Health related qulaity of life, Glivec