Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 10:29 PM
Study NCT ID:
NCT01394666
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2011-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-08', 'studyFirstSubmitDate': '2011-07-08', 'studyFirstSubmitQcDate': '2011-07-13', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily', 'timeFrame': 'At 3 months post treatment change'}, {'measure': 'Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily', 'timeFrame': 'At 6 months post treatment change'}, {'measure': 'Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily', 'timeFrame': 'At 12 months post treatment change'}], 'secondaryOutcomes': [{'measure': 'Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily', 'timeFrame': 'Baseline'}, {'measure': 'Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily', 'timeFrame': '3 months after start of treatment'}, {'measure': 'Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily', 'timeFrame': '6 months after start of treatment'}, {'measure': 'Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily', 'timeFrame': '12 months after start of treatment'}, {'measure': 'Best response rates achieved by patients if no CCyR', 'timeFrame': 'Baseline'}, {'measure': 'Best response rates achieved by patients if no CCyR', 'timeFrame': '3 months after start of treatment'}, {'measure': 'Best response rates achieved by patients if no CCyR', 'timeFrame': '6 months after start of treatment'}, {'measure': 'Best response rates achieved by patients if no CCyR', 'timeFrame': '12 months after start of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Myeloid Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/home.aspx', 'label': 'BMS Clinical Trials Disclosure'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.', 'detailedDescription': 'Time Perspective: Retrospective and Prospective'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic, academic and community oncology centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\n* Adult patients (18 years or older) in Chronic phase CML patients who have been treated with Imatinib 400 mg and have failed.'}, 'identificationModule': {'nctId': 'NCT01394666', 'briefTitle': 'Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Treatment Patterns and Associated Outcomes in Chronic Phase (CP) Chronic Myelogenous Leukemia (CML) Patients Who Fail Imatinib 400 mg Daily', 'orgStudyIdInfo': {'id': 'CA180-240'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CP-CML patients who have failed Imatinib 400 mg daily'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}