Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan

Study Overview
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Brief Summary
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This study assessed the efficacy and safety of generic imatinib in patients with chronic myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label, prospective study combined with retrospective data collection from files of patients with a diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s) additional to the daily practice were performed

Detailed Description
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Primary objectives Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated with Cemivil who achieve optimal response : Complete hematologic response (CHR) at 3 months; Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response (PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months (No Ph+ metaphases); Major molecular response (MMR) at 12 months of Cemivil therapy [a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale]; Assess the safety and tolerability of Cemivil after one year of treatment, based on: Incidence, severity, and relationship of adverse events (AEs) to the study medication; Serious AEs; AEs leading to permanent treatment discontinuation; Clinically relevant changes in laboratory tests (according to laboratory reference ranges). Number of Subjects evaluated: 91 (N=33 received generic imatinib as first-line therapy first-line patients. N=58 switched from patented imatinib to generic imatinib switched patients)

Official Title
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Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan

Conditions
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Chronic Myeloid Leukemia, Chronic Phase

Intervention / Treatment
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* Drug: Imatinib


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; or CML patients who started with Cemivil treatment since its registration in Jordan and who confirmed CHR Written informed consent Exclusion Criteria: Age <18 years CML in accelerated phase CML in blast crisis CML with mutation(s) in the BCR-ABL gene Contraindications to the administration of the study drug according to the approved Summary of Product Characteristics (SPC)

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

| Intervention/Treatment |
| --- |
|Drug: Imatinib|Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complete Cytogenetic Response (CCyR) |  | 12 months | 
| Rate of Major Molecular Response (MMR) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (AEs) | (Safety & Tolerability) | 12 months |