Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT00337194
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2006-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C504717', 'term': 'SGN-30 monoclonal antibody'}, {'id': 'D000079963', 'term': 'Brentuximab Vedotin'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kristie.blum@osumc.edu', 'title': 'Dr. Kristie Blum', 'organization': 'The Ohio State University'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm I (SGN-30, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nmonoclonal antibody SGN-30: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies', 'otherNumAtRisk': 23, 'otherNumAffected': 21, 'seriousNumAtRisk': 23, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Arm II (Placebo, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nplacebo: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharma', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 31, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cardiac pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ear, nose and throat examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Joint- Late RT Morbidity Scoring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Visceral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Upper aerodigestive tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Leukocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 32, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Joint disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum magnesium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum phosphate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Body odor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hand-and-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Photosensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Overall Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SGN-30, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nmonoclonal antibody SGN-30: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nplacebo: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 years', 'description': 'The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): \\>= 50% reduction in sum of the product of diameters of indicator lesions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SGN-30, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nmonoclonal antibody SGN-30: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nplacebo: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'comment': 'he upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': 'NA'}, {'value': '4.1', 'comment': 'he upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 years', 'description': 'Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) At 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SGN-30, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nmonoclonal antibody SGN-30: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nplacebo: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '95'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peak Serum Level of Monoclonal Antibody SGN-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SGN-30, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nmonoclonal antibody SGN-30: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '565'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to day 21 of course 6', 'description': 'Record the highest serum level of monoclonal antibody SGN-30 achieved.', 'unitOfMeasure': 'mg/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was only available on 10 participants from Arm 1. (No participants from Arm II were evaluable for this endpoint as they did not receive SGN-30 per protocol.)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'sCD30 Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Subset of patients who achieved an overall response, as describer in primary outcome measure 1.'}, {'id': 'OG001', 'title': 'Non-responders', 'description': 'Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1'}], 'classes': [{'categories': [{'measurements': [{'value': '174.2', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '1992.0'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '219.0'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to day 21 of course 6', 'description': 'A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups.', 'unitOfMeasure': 'U/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine participants submitted pretreatment sCD30 samples.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fc Gamma Receptor Polymorphisms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Subset of patients who achieved an overall response, as describer in primary outcome measure 1.'}, {'id': 'OG001', 'title': 'Non-responders', 'description': 'Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1'}], 'classes': [{'title': 'V/V', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'F/F', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'F/V', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "Fisher's exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Fc gamma receptor polymorphisms were assessed in 28 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (SGN-30, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nmonoclonal antibody SGN-30: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}, {'id': 'FG001', 'title': 'Arm II (Placebo, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nplacebo: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subsequent non-protocol therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'From April 2006 to December 2007 10 institutions recruited 30 participants to this trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (SGN-30, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nmonoclonal antibody SGN-30: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}, {'id': 'BG001', 'title': 'Arm II (Placebo, Chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.\n\nplacebo: Given IV\n\nvinorelbine tartrate: Given IV\n\npegylated liposomal doxorubicin hydrochloride: Given IV\n\ngemcitabine hydrochloride: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '78'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '53'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior autologous transplant', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2006-06-13', 'resultsFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2006-06-13', 'lastUpdatePostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-10', 'studyFirstPostDateStruct': {'date': '2006-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Peak Serum Level of Monoclonal Antibody SGN-30', 'timeFrame': 'Up to day 21 of course 6', 'description': 'Record the highest serum level of monoclonal antibody SGN-30 achieved.'}, {'measure': 'sCD30 Levels', 'timeFrame': 'Up to day 21 of course 6', 'description': 'A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups.'}, {'measure': 'Fc Gamma Receptor Polymorphisms', 'timeFrame': 'Baseline', 'description': "Fisher's exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a"}], 'primaryOutcomes': [{'measure': 'Number of Participants With Overall Response (OR)', 'timeFrame': 'Up to 10 years', 'description': 'The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): \\>= 50% reduction in sum of the product of diameters of indicator lesions.'}], 'secondaryOutcomes': [{'measure': 'Event Free Survival (EFS)', 'timeFrame': 'Up to 10 years', 'description': 'Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.'}, {'measure': 'Overall Survival (OS) At 1 Year', 'timeFrame': '1 year', 'description': 'Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method.'}]}, 'conditionsModule': {'conditions': ['Adult Lymphocyte Depletion Hodgkin Lymphoma', 'Adult Lymphocyte Predominant Hodgkin Lymphoma', 'Adult Mixed Cellularity Hodgkin Lymphoma', 'Adult Nodular Sclerosis Hodgkin Lymphoma', 'Recurrent Adult Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the complete and partial response rates following treatment with the anti-cluster of differentiation (CD) 30 antibody, SGN-30 (monoclonal antibody SGN-30), and gemcitabine (gemcitabine hydrochloride), vinorelbine (vinorelbine tartrate), and pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) (GVD) in patients with relapsed or refractory Hodgkin lymphoma (HL).\n\nII. To assess time to progression and overall survival in patients treated with SGN-30 and GVD in patients with relapsed or refractory Hodgkin lymphoma (HL).\n\nIII. To evaluate the toxicity of SGN-30 in combination with GVD in patients with relapsed and refractory HL.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the pharmacokinetic profile of SGN-30 when combined with GVD chemotherapy.\n\nII. To correlate soluble (s) CD30 levels with response to treatment. III. To determine the incidence of human anti-chimeric antibodies (HACA) formation following repetitive SGN-30 dosing.\n\nIV. To correlate Fc gamma receptor polymorphisms with response to treatment.\n\nOUTLINE:\n\nPart 1 (closed to accrual as of 5/18/2007): Patients receive monoclonal antibody SGN-30 intravenously (IV) over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days until 10 out of 16 patients complete 1 course in the absence of unacceptable toxicity. Subsequent patients receive treatment on part 2.\n\nPart 2: Patients are randomized to 1 of 2 treatment arms.\n\nArm I: Patients receive monoclonal antibody SGN-30 IV over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8.\n\nArm II (closed to accrual as of 12/4/07): Patients receive placebo IV over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8.\n\nTreatment in both arms repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nNOTE: Treatment with SGN-30/placebo was stopped on 4/12/2007 due to pulmonary toxicity.\n\nAfter completion of study treatment, patients are followed up periodically for up to 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically documented CD30-positive classical Hodgkin lymphoma according to the World Health Organization (WHO) classification of lymphoid malignancies that is recurrent or refractory after at least one prior therapy\n\n * Note: Patients with nodular lymphocyte predominant HL are not eligible; all other subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte rich, and mixed cellularity HL may be enrolled\n * Core needle biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable; if the original diagnostic specimen is not available, specimens obtained at relapse may be submitted; if multiple specimens are available, please submit the most recent; failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation\n* Patients must have relapsed or refractory disease after at least one prior therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen; recovery to =\\< grade 1 from all toxicities related to the prior treatments is required; patients who have previously received a stem cell transplant are permitted to enroll on this study\n\n * Prior treatment with an anti-CD30 antibody, gemcitabine, vinorelbine, or pegylated liposomal doxorubicin is not permitted\n* No uncontrolled angina, no myocardial infarction (MI) within 6 months of study entry, and no New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)\n* Baseline left ventricular ejection fraction (LVEF) by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) must be \\>= 45%\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Measurable disease must be present on either physical examination or imaging studies; evaluable or non-measurable disease alone is not acceptable\n\n * Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\>= 10 mm\n * Non-measurable disease includes all other lesions, including small lesions (\\< 10 mm) and truly non-measurable lesions\n * Lesions that are considered non-measurable include the following:\n\n * Bone lesions (lesions, if present, should be noted)\n * Bone marrow involvement (if present, this should be noted)\n * Ascites\n * Pleural/pericardial effusion\n * Lymphangitis cutis/pulmonis\n* Pregnant or nursing women may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test prior to registration; women and men of reproductive potential should agree to use an effective means of birth control\n* Corrected diffusion capacity of carbon monoxide (DLCO) \\>= 50%\n* Absolute neutrophil count (ANC) \\>= 1,200/uL\n* Platelet count \\>= 100,000/uL\n* Creatinine =\\< 2.0 mg/dL\n* Bilirubin =\\< 2.0 mg/dL\n\n * Absent a history of Gilbert's disease\n* Aspartate aminotransferase (AST) =\\< 2.0 x upper limits of normal"}, 'identificationModule': {'nctId': 'NCT00337194', 'briefTitle': 'SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636), in Combination With Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients With Relapsed/Refractory Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'NCI-2012-02822'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02822', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CALGB-50502', 'type': 'OTHER', 'domain': 'Cancer and Leukemia Group B'}, {'id': 'CALGB-50502', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'P30CA014236', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014236', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (SGN-30, chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.', 'interventionNames': ['Biological: monoclonal antibody SGN-30', 'Drug: vinorelbine tartrate', 'Drug: pegylated liposomal doxorubicin hydrochloride', 'Drug: gemcitabine hydrochloride', 'Other: laboratory biomarker analysis', 'Other: pharmacological study']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (placebo, chemotherapy)', 'description': 'Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.\n\nNo prior stem cell transplant:\n\nSGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 20 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 1000 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \\& 8.\n\nPrior stem cell transplant SGN-30: 12 mg/kg IV days 1 \\& 8, vinorelbine: 15 mg/m\\^2 IV days 1 \\& 8, gemcitabine: 800 mg/m\\^2 IV days 1 \\& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \\& 8.', 'interventionNames': ['Other: placebo', 'Drug: vinorelbine tartrate', 'Drug: pegylated liposomal doxorubicin hydrochloride', 'Drug: gemcitabine hydrochloride', 'Other: laboratory biomarker analysis', 'Other: pharmacological study']}], 'interventions': [{'name': 'monoclonal antibody SGN-30', 'type': 'BIOLOGICAL', 'otherNames': ['SGN-30'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (SGN-30, chemotherapy)']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given IV', 'armGroupLabels': ['Arm II (placebo, chemotherapy)']}, {'name': 'vinorelbine tartrate', 'type': 'DRUG', 'otherNames': ['Eunades', 'navelbine ditartrate', 'NVB', 'VNB'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (SGN-30, chemotherapy)', 'Arm II (placebo, chemotherapy)']}, {'name': 'pegylated liposomal doxorubicin hydrochloride', 'type': 'DRUG', 'otherNames': ['CAELYX', 'Dox-SL', 'DOXIL', 'doxorubicin hydrochloride liposome', 'LipoDox'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (SGN-30, chemotherapy)', 'Arm II (placebo, chemotherapy)']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'otherNames': ['dFdC', 'difluorodeoxycytidine hydrochloride', 'gemcitabine', 'Gemzar'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (SGN-30, chemotherapy)', 'Arm II (placebo, chemotherapy)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (SGN-30, chemotherapy)', 'Arm II (placebo, chemotherapy)']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (SGN-30, chemotherapy)', 'Arm II (placebo, chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60606', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer and Leukemia Group B', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Kristie Blum', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer and Leukemia Group B'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}