Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT07150793
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan
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': 754}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients by Line of Treatment (LoT) and TKI Received', 'timeFrame': 'Up to approximately 9 years', 'description': 'TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.'}, {'measure': 'Number of Patients who Switched TKI Treatment by LoT and TKI', 'timeFrame': 'Up to approximately 9 years', 'description': 'TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.'}, {'measure': 'Number of Patients who Discontinued TKI Treatment by Type of TKI', 'timeFrame': 'Up to approximately 9 years', 'description': 'TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.'}, {'measure': 'Number of Patients who Discontinued TKI Treatment for at Least One Year by Type of TKI', 'timeFrame': 'Up to approximately 9 years', 'description': 'TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.'}, {'measure': 'Number of Patients who Restarted any TKI Treatment After Discontinuing the TKI of Interest by Type of TKI', 'timeFrame': 'Up to approximately 9 years', 'description': 'TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.'}, {'measure': 'TKI Dose by LoT', 'timeFrame': 'Baseline, up to approximately 9 years', 'description': 'TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.'}, {'measure': 'TKI Persistence Rate by LoT', 'timeFrame': 'Months 6, 12, 18, and Year 5'}, {'measure': 'Duration of TKI Treatment by LoT', 'timeFrame': 'Up to approximately 9 years'}], 'secondaryOutcomes': [{'measure': 'Annual Incidence of Inpatient and Outpatient Visits by LoT', 'timeFrame': 'Up to approximately 9 years'}, {'measure': 'Annual Mean Cost of All-cause Healthcare Resource Use by LoT', 'timeFrame': 'Up to approximately 9 years', 'description': 'All-cause care included inpatient and outpatient visits. The following costs were calculated in Japanese yen (JPN):\n\n* Total costs\n* Inpatient costs\n* Outpatient costs\n* Pharmacy costs'}, {'measure': 'Annual Incidence of CML-related Healthcare Resource Use by LoT', 'timeFrame': 'Up to approximately 9 years', 'description': 'CML-related care included:\n\n* Major BCR-ABL1 procedures (diagnostic and response to treatment testing)\n* Complete blood count testing - peripheral blood general testing\n* Hematological examination diagnosis fee\n* TKI prescriptions'}, {'measure': 'Annual Mean Cost of CML-related Healthcare Resource Use by LoT', 'timeFrame': 'Up to approximately 9 years', 'description': 'CML-related care costs were calculated in Japanese Yen (JPY) and included the following:\n\n* Total CML-related costs\n* Major BCR-ABL1 procedure costs\n* Complete blood count testing - peripheral blood general testing costs\n* Hematological examination costs\n* TKI prescription costs'}, {'measure': 'Number of Patients With Adverse Events by TKI', 'timeFrame': 'Up to approximately 9 years', 'description': 'TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.'}]}, 'conditionsModule': {'keywords': ['Tyrosine Kinase Inhibitor', 'Real-world'], 'conditions': ['Myeloid Leukemia, Chronic']}, 'descriptionModule': {'briefSummary': 'The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan.\n\nThis was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The index date was the date of the first prescription of any TKI of interest registered within the selection period (01 January 2011 to 31 December 2019). The follow-up period was from the index date until the end of the study period, end of continuous follow-up in the MDV database, or death, whichever came first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, non-interventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients who met all the below inclusion criteria and none of the exclusion criteria were included in the study.\n\nInclusion criteria:\n\n* Patients who had at least one TKI prescription during the selection period,\n* a confirmed diagnosis of chronic phase CML recorded before or at the index date,\n* were aged 15 years or older at the index date, and\n* had at least 12-months continuous pre-index period.\n\nExclusion criteria:\n\n* Patients who had at least one TKI prescription in the 12 months preceding the index date (washout period to catch the 1st line of treatment \\[LoT\\]),\n* a confirmed diagnosis of CML blast crisis or accelerated phase recorded prior to, at, or within 6 months after the index date,\n* a confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) within 6 months after the index date,\n* a medical record of chemotherapy (not including hydroxyurea) within 6 months after the index date,\n* a stem cell transplant procedure recorded during the pre-index period.'}, 'identificationModule': {'nctId': 'NCT07150793', 'briefTitle': 'A Study of Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan - A Retrospective Claims Database Analysis', 'orgStudyIdInfo': {'id': 'CAMN107AJP11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CML Cohort', 'description': 'Patients diagnosed with chronic phase CML who received treatment with a TKI in Japan between 01 January 2011 and 31 December 2019.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}