Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT03454503
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2018-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who achieve and maintain major molecular response (MMR)', 'timeFrame': '12 months', 'description': 'Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®)', 'timeFrame': '18 months', 'description': 'Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '18 months', 'description': 'Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.'}, {'measure': 'Event free survival (EFS)', 'timeFrame': '18 months', 'description': 'Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint'}, {'measure': 'Survival without blastic phase (BP)', 'timeFrame': '18 months', 'description': 'Proportion of CML patients who will not experience blastic phase (BP) from enrollment to 18 months study endpoint.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '18 months', 'description': 'Proportion of CML patients who will not die till 18 months study endpoint.'}, {'measure': 'Complete cytogenetic response (CCgR)', 'timeFrame': '12 months', 'description': 'Proportion of CML patients who will achieve no Ph+ metaphases at 12 months study endpoint by conventional cytogenetics and/or FISH test.'}, {'measure': 'Complete molecular response (CMR)', 'timeFrame': '12 months', 'description': 'Proportion of CML patients who will achieve undetectable BCR-ABL mRNA transcripts by RQ-PCR test in two consecutive blood samples of adequate quality.'}, {'measure': 'Health-Related Quality of Life (HRQoL)', 'timeFrame': '18 months', 'description': 'Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits'}, {'measure': 'Treatment compliance on generic Imatinib', 'timeFrame': '18 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Imatinib', 'Generic Imatinib', 'Leukemia', 'Chronic myeloid leukemia', 'Philadelphia chromosome-positive', 'Chronic phase', 'Observational study', 'Switched patients', 'Tyrosine kinase inhibitor'], 'conditions': ['Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nEligible Ph+ CML patients in both cohorts will be followed up for a total of 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from 2 sites in Egypt', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFirst cohort (newly diagnosed patients):\n\n* Age ≥18 years\n* Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis\n* Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment\n* 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\n* Written informed consent\n\nSecond cohort (switched patients):\n\n* Age ≥18 years\n* Ph+ CML patients in CP currently treated with Glivec®, with or without the presence of other cytogenetic abnormalities at the time of switch\n* 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\n* Written informed consent\n\nExclusion Criteria:\n\n* CML in accelerated phase (AP) at enrollment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis\n* CML in BP at enrollment\n* Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics'}, 'identificationModule': {'nctId': 'NCT03454503', 'briefTitle': 'Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hikma Pharmaceuticals LLC'}, 'officialTitle': 'Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt', 'orgStudyIdInfo': {'id': 'CRC-EGY-2016-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First cohort', 'description': 'Newly diagnosed patients', 'interventionNames': ['Drug: Imatinib']}, {'label': 'Second cohort', 'description': 'Patients switched from reference product (Glivec® )', 'interventionNames': ['Drug: Imatinib']}], 'interventions': [{'name': 'Imatinib', 'type': 'DRUG', 'otherNames': ['Carcemia®'], 'description': 'Film coated tablet contains 400 mg imatinib (as mesilate)', 'armGroupLabels': ['First cohort', 'Second cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute (NCI)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hikma Pharmaceuticals LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}