Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT04307134
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2020-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Besponsa Post Marketing Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-10'}], 'estimatedResultsFirstSubmitDate': '2025-12-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080045', 'term': 'Inotuzumab Ozogamicin'}], 'ancestors': [{'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events categorized according to physical organ and disease/symptom', 'timeFrame': '28 days following the last administration of BESPONSA®.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Refractory and relapsed B-cell ALL'], 'conditions': ['Hematologic Maligmancy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1931027', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.', 'detailedDescription': 'Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered in the setting of routine practice in Korea during the initial 6 years after the approval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nPatients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).\n2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n\nExclusion criteria\n\nPatients meeting any of the following criteria will not be included in the study:\n\n1. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.\n2. Patients to whom BESPONSA® is contraindicated as per the local labeling.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT04307134', 'briefTitle': 'Besponsa Post Marketing Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)', 'orgStudyIdInfo': {'id': 'B1931027'}, 'secondaryIdInfos': [{'id': 'NCT04307134', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'R/R ALL', 'description': 'Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL)', 'interventionNames': ['Drug: Inotuzumab ozogamicin']}], 'interventions': [{'name': 'Inotuzumab ozogamicin', 'type': 'DRUG', 'description': 'R/R ALL who treated with Inotuzumab ozogamicin', 'armGroupLabels': ['R/R ALL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}