Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-30 @ 2:14 AM
Study NCT ID:
NCT01315457
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2011-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infections Associated With the Use of Alemtuzumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-22', 'studyFirstSubmitDate': '2011-03-13', 'studyFirstSubmitQcDate': '2011-03-13', 'lastUpdatePostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infectious event', 'timeFrame': 'one year', 'description': 'Any infectious complication occurred within one year after the use of alemtuzumab'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alemtuzumab, infection, prophylaxis, treatment'], 'conditions': ['Patients Treated With Alemtuzumab']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to propose infection prophylaxis from Asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients received alemtuzumab as a treatment for hematologic malignancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients received alemtuzumab as a treatment for hematologic malignancy ex. non-Hodgkin lymphoma Acute myeloid leukemia Aplastic anemia\n\nExclusion Criteria:\n\n* Patients did not receive alemtuzumab'}, 'identificationModule': {'nctId': 'NCT01315457', 'briefTitle': 'Infections Associated With the Use of Alemtuzumab', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Asian Multinational Retrospective Analysis for Infectious Complications in Patients Treated With Alemtuzumab', 'orgStudyIdInfo': {'id': '2009-03-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alemtuzumab', 'description': 'Patients treated with alemtuzumab'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo General Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Teipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital'}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Won Seog Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, {'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Soon Chun Hyang University', 'class': 'OTHER'}, {'name': 'Chonnam National University', 'class': 'OTHER'}, {'name': 'Chonbuk National University', 'class': 'OTHER'}, {'name': 'Chulalongkorn University', 'class': 'OTHER'}, {'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}, {'name': 'Yonsei University', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Seog Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}