Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-04-10 @ 2:08 AM
Study NCT ID:
NCT00529503
Status:
TERMINATED
Last Update Posted:
2015-02-25
First Post:
2007-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543331', 'term': 'dacetuzumab'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D007069', 'term': 'Ifosfamide'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'dispFirstSubmitDate': '2011-06-16', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-06', 'studyFirstSubmitDate': '2007-09-11', 'dispFirstSubmitQcDate': '2011-06-16', 'studyFirstSubmitQcDate': '2007-09-12', 'dispFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.', 'timeFrame': '9 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse events, laboratory values, and anti-drug antibody immune responses.', 'timeFrame': '9 weeks'}, {'measure': 'Partial response, failure free survival, overall survival, and response for one and two years following treatment.', 'timeFrame': 'Every 3 months for 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lymphoproliferative Disorders', 'Lymphoma', 'Antigens, CD40', 'Antibody, Monoclonal', 'Combined Modality Therapy', 'Lymphoma, Large B-Cell, Diffuse', 'Lymphoma, Non-Hodgkin', 'Hematologic Diseases', 'Immunoproliferative Disorders', 'Lymphatic Diseases'], 'conditions': ['Lymphoma, Large B-Cell, Diffuse', 'Lymphoma, Non-Hodgkin']}, 'referencesModule': {'references': [{'pmid': '25651427', 'type': 'RESULT', 'citation': 'Fayad L, Ansell SM, Advani R, Coiffier B, Stuart R, Bartlett NL, Forero-Torres A, Kuliczkowski K, Belada D, Ng E, Drachman JG. Dacetuzumab plus rituximab, ifosfamide, carboplatin and etoposide as salvage therapy for patients with diffuse large B-cell lymphoma relapsing after rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone: a randomized, double-blind, placebo-controlled phase 2b trial. Leuk Lymphoma. 2015;56(9):2569-78. doi: 10.3109/10428194.2015.1007504. Epub 2015 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma.\n* Received at least four cycles of first-line therapy with R-CHOP, or equivalent.\n* Best clinical response to first-line therapy of stable disease, partial response, or complete response.\n* At least one measureable lesion that is both greater than or equal to 1.5cm by radiographic imaging and by positive FDG-PET scan.\n\nExclusion Criteria:\n\n* Leptomeningeal or central nervous system lymphoma.\n* Received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab.\n* Received a hematopoietic stem cell transplant.'}, 'identificationModule': {'nctId': 'NCT00529503', 'briefTitle': 'A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seagen Inc.'}, 'officialTitle': 'A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)', 'orgStudyIdInfo': {'id': 'SG040-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'SGN-40, rituximab, etoposide, carboplatin, ifosfamide', 'interventionNames': ['Drug: SGN-40', 'Drug: rituximab', 'Drug: etoposide', 'Drug: carboplatin', 'Drug: ifosfamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo, rituximab, etoposide, carboplatin, ifosfamide', 'interventionNames': ['Drug: placebo', 'Drug: rituximab', 'Drug: etoposide', 'Drug: carboplatin', 'Drug: ifosfamide']}], 'interventions': [{'name': 'SGN-40', 'type': 'DRUG', 'otherNames': ['dacetuzumab'], 'description': '2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.', 'armGroupLabels': ['2']}, {'name': 'rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan'], 'description': '375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1', 'armGroupLabels': ['1', '2']}, {'name': 'etoposide', 'type': 'DRUG', 'otherNames': ['Toposar, Vepesid'], 'description': '100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.', 'armGroupLabels': ['1', '2']}, {'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'AUC=5 mg/mL min IV. Cycles 1-3: Day 2.', 'armGroupLabels': ['1', '2']}, {'name': 'ifosfamide', 'type': 'DRUG', 'otherNames': ['Ifex'], 'description': '5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.', 'armGroupLabels': ['1', '2']}]}, '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': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305-5821', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Systems', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'MD Anderson Cancer Center, Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute, Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville - 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