Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-01 @ 12:16 AM
Study NCT ID:
NCT02977312
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], 'ancestors': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic 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': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Complete Cytogenetic Response (CCyR)', 'timeFrame': '12 months'}, {'measure': 'Rate of Major Molecular Response (MMR)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (AEs)', 'timeFrame': '12 months', 'description': '(Safety \\& Tolerability)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Myeloid Leukemia, Chronic Phase']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Primary objectives\n\nMeasure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated with Cemivil who achieve optimal response :\n\n* Complete hematologic response (CHR) at 3 months;\n* 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);\n* Major molecular response (MMR) at 12 months of Cemivil therapy \\[a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale\\];\n\nAssess the safety and tolerability of Cemivil after one year of treatment, based on:\n\n* Incidence, severity, and relationship of adverse events (AEs) to the study medication;\n* Serious AEs;\n* AEs leading to permanent treatment discontinuation;\n* Clinically relevant changes in laboratory tests (according to laboratory reference ranges).\n\nNumber 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")'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* 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\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\<18 years\n* CML in accelerated phase\n* CML in blast crisis\n* CML with mutation(s) in the BCR-ABL gene\n* Contraindications to the administration of the study drug according to the approved Summary of Product Characteristics (SPC)'}, 'identificationModule': {'nctId': 'NCT02977312', 'acronym': 'CCMLJ', 'briefTitle': 'Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hikma Pharmaceuticals LLC'}, 'officialTitle': 'Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan', 'orgStudyIdInfo': {'id': 'Cemivil-2011-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Imatinib', 'type': 'DRUG', 'otherNames': ['Cemivil'], 'description': 'Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amman', 'country': 'Jordan', 'facility': 'Al Bashir Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'city': 'Amman', 'country': 'Jordan', 'facility': 'Jordan University Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'city': 'Amman', 'country': 'Jordan', 'facility': 'King Hussein Cancer Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Abdallah Abbadi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hikma Pharmaceuticals LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}