Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-01 @ 11:37 AM
Study NCT ID:
NCT05665192
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2022-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Real-World Patient-Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2022-12-16', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)', 'timeFrame': 'Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)'}, {'measure': 'Absolute change in TSS assessed by MFSAF', 'timeFrame': 'At Baseline, 3 and 6 months post-FEDR initiation'}, {'measure': 'Proportion of participants reporting individual symptoms in TSS assessed by MFSAF', 'timeFrame': 'At Baseline, 3 and 6 months post-FEDR initiation'}, {'measure': 'Severity of each reported symptom in TSS assessed by MFSAF', 'timeFrame': 'At Baseline, 3 and 6 months post-FEDR initiation'}, {'measure': "Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC)", 'timeFrame': 'At Baseline, 3 and 6 months post-FEDR initiation'}, {'measure': 'Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)', 'timeFrame': 'At Baseline, 3 and 6 months post-FEDR initiation'}]}, 'conditionsModule': {'keywords': ['Primary Myelofibrosis', 'Thrombocythemia Myelofibrosis', 'Fedratinib', 'Ruxolitinib'], 'conditions': ['Myelofibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of participants who have discontinued RUX and will be initiating FEDR prospectively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Primary myelofibrosis (PMF), post- Essential thrombocythemia (ET) Myelofibrosis (MF), or post- Polycythemia vera (PV) MF\n* Treated with FEDR and initiated treatment after 16 August 2019.\n* Received prior treatment with RUX.\n* Had spleen assessed at time of initiation of FEDR by palpation.\n* Able to read and speak English\n* Willing to provide informed consent\n* Willing to provide permission to the site to release her/his medical information to the study investigators according to the study-specific eCRF\n* Willing to complete the baseline survey prior to first FEDR\n\nExclusion Criteria:\n\n* Past or current participant in any FEDR-related clinical trial'}, 'identificationModule': {'nctId': 'NCT05665192', 'briefTitle': 'A Study to Assess Real-World Patient-Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Real-World Clinical and Patient Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib', 'orgStudyIdInfo': {'id': 'CA054-1014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Participants that have discontinued RUX therapy and initiated FEDR prospectively'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cardinal Health Specialty Solutions', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}