Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT01187303
Status:
COMPLETED
Last Update Posted:
2015-11-02
First Post:
2010-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'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': 'C527517', 'term': 'ofatumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2010-08-19', 'studyFirstSubmitQcDate': '2010-08-23', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '12 months after end of treatment'}], 'secondaryOutcomes': [{'measure': 'duration of response', 'timeFrame': '12 months after end of treatment'}, {'measure': 'Progression free survival', 'timeFrame': '12 months after end of treatment'}, {'measure': 'adverse events', 'timeFrame': '12 months after end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Relapsed NLPHL']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ww.ghsg.org', 'label': 'Homepage of the German Hodgkin Study Group'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* relapsed nodular lymphocyte predominant hodgkin lymphoma\n* age 18 - 75\n* review of diagnosis by experienced pathologist\n* no major organ dysfunction\n\nExclusion Criteria:\n\n* classical hodgkin lymphoma\n* CD20 antibody treatment within the last 6 months prior enrollment\n* chronic or current infectious disease requirering systemic antibiotics\n* other past or current malignancy'}, 'identificationModule': {'nctId': 'NCT01187303', 'briefTitle': 'Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)', 'orgStudyIdInfo': {'id': 'Uni-Koeln-1432'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ofatumumab', 'type': 'DRUG', 'description': '300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': '1st Department of Medicine, Cologne University Hospital', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Andreas Engert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Prof. Dr. Andreas Engert', 'investigatorAffiliation': 'University of Cologne'}}}}