Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 4:07 PM
Study NCT ID:
NCT01026233
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Safety Study of Brentuximab Vedotin (SGN-35)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079963', 'term': 'Brentuximab Vedotin'}], 'ancestors': [{'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'nctId': 'NCT01196208', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-11', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-03', 'lastUpdatePostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QTc interval', 'timeFrame': '2-4 days postdose'}], 'secondaryOutcomes': [{'measure': 'ECG parameters', 'timeFrame': '2-4 days postdose'}, {'measure': 'Blood MMAE levels', 'timeFrame': 'Through 4 days postdose'}, {'measure': 'Incidence of proarrhythmic adverse events', 'timeFrame': 'Through 1 month following last dose'}, {'measure': 'Incidence of adverse events and laboratory abnormalities', 'timeFrame': 'Through 1 month following last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antibodies, Monoclonal', 'Antibody-Drug Conjugate', 'Antigens, CD30', 'Disease, Hodgkin', 'Drug Therapy', 'Hematologic Diseases', 'Immunotherapy', 'Lymphoma', 'monomethylauristatin E', 'Lymphoma, Large-Cell, Anaplastic'], 'conditions': ['Disease, Hodgkin', 'Lymphoma, Large-Cell, Anaplastic', 'Lymphoma, Non-Hodgkin']}, 'referencesModule': {'references': [{'pmid': '23719719', 'type': 'RESULT', 'citation': 'Han TH, Chen R, Advani R, Berryman RB, Smith SE, Forero-Torres A, Rosenblatt JD, Smith MR, Zain J, Hunder NN, Engert A. Brentuximab vedotin does not cause clinically relevant QTc interval prolongation in patients with CD30-positive hematologic malignancies. Cancer Chemother Pharmacol. 2013 Jul;72(1):241-9. doi: 10.1007/s00280-013-2192-z. Epub 2013 May 30.'}, {'pmid': '22786877', 'type': 'DERIVED', 'citation': 'Rothe A, Sasse S, Goergen H, Eichenauer DA, Lohri A, Jager U, Bangard C, Boll B, von Bergwelt Baildon M, Theurich S, Borchmann P, Engert A. Brentuximab vedotin for relapsed or refractory CD30+ hematologic malignancies: the German Hodgkin Study Group experience. Blood. 2012 Aug 16;120(7):1470-2. doi: 10.1182/blood-2012-05-430918. Epub 2012 Jul 11.'}, {'pmid': '22510871', 'type': 'DERIVED', 'citation': "Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsed or refractory CD30-positive malignancy\n* Adequate organ function\n* ECOG performance status \\<2\n\nExclusion Criteria:\n\n* Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)\n* Current diagnosis of primary cutaneous ALCL\n* Acute or chronic graft-versus-host disease\n* Prior hematopoietic stem cell transplant within specified timeframe'}, 'identificationModule': {'nctId': 'NCT01026233', 'briefTitle': 'Cardiac Safety Study of Brentuximab Vedotin (SGN-35)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seagen Inc.'}, 'officialTitle': 'An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies', 'orgStudyIdInfo': {'id': 'SGN35-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'brentuximab vedotin', 'interventionNames': ['Drug: brentuximab vedotin']}], 'interventions': [{'name': 'brentuximab vedotin', 'type': 'DRUG', 'otherNames': ['SGN-35'], 'description': '1.8 mg/kg IV every 21 days', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital and Clinics, Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cardinal Bernardin Cancer Center / Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Cancer Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Naomi Hunder, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seagen Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seagen Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}