Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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First cohort Newly diagnosed patients |
Drug: Imatinib
Film coated tablet contains 400 mg imatinib (as mesilate)
Other Names:
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Second cohort Patients switched from reference product (Glivec® ) |
Drug: Imatinib
Film coated tablet contains 400 mg imatinib (as mesilate)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
First cohort (newly diagnosed patients):
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Age ≥18 years
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Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
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Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
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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
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Written informed consent
Second cohort (switched patients):
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Age ≥18 years
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Ph+ CML patients in CP currently treated with Glivec®, with or without the presence of other cytogenetic abnormalities at the time of switch
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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
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Written informed consent
Exclusion Criteria:
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CML in accelerated phase (AP) at enrollment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis
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CML in BP at enrollment
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Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | National Cancer Institute (NCI) | Cairo | Egypt | 11796 |
Sponsors and Collaborators
- Hikma Pharmaceuticals LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRC-EGY-2016-05