Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 5:32 PM
Study NCT ID:
NCT01470456
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'C569646', 'term': 'coltuximab ravtansine'}, {'id': 'D000069283', 'term': 'Rituximab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-12', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants achieving an Objective Response Rate', 'timeFrame': '18 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events', 'timeFrame': 'Up to 6 months'}, {'measure': 'Response Duration -Time', 'timeFrame': 'Up to 24 months after the first infusion of the last patient'}, {'measure': 'Progression Free Survival -Time', 'timeFrame': 'Up to 24 months after the first infusion of the last patient'}, {'measure': 'Overall survival -Time', 'timeFrame': 'Up to 24 months after the first infusion of the last patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diffuse Large B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nParticipants Achieving an Objective Response Rate (Cheson 2007)\n\nSecondary Objectives:\n\n* Progression Free Survival\n* Overall Survival\n* Response Duration', 'detailedDescription': '* The screening period = up to 4 weeks prior to the first administration of combined therapy\n* The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients.\n* The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL)\n* Relapsed or refractory after at least one standard treatment including rituximab\n* CD19 and CD20 positive disease\n\nExclusion criteria:\n\n* No bi-dimensionally measurable lesion by CT scan (defined as presence of at least one tumor mass measuring \\>1.5 x 1.5 cm)\n* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01470456', 'briefTitle': 'Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas', 'orgStudyIdInfo': {'id': 'TCD12333'}, 'secondaryIdInfos': [{'id': '2011-002865-39'}, {'id': 'U1111-1120-0315', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAR3419 + Rituximab', 'description': 'Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.', 'interventionNames': ['Drug: SAR3419', 'Drug: rituximab']}], 'interventions': [{'name': 'SAR3419', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution for infusion Route of administration: Intravenous', 'armGroupLabels': ['SAR3419 + Rituximab']}, {'name': 'rituximab', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution for infusion Route of administration: intravenous', 'armGroupLabels': ['SAR3419 + Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Investigational Site Number 040002', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Investigational Site Number 250004', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Investigational Site Number 250009', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Investigational Site Number 250006', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Investigational Site Number 250011', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Investigational Site Number 250010', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Investigational Site Number 250008', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Investigational Site Number 250007', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Investigational Site Number 250001', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Investigational Site Number 250005', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Investigational Site Number 250003', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Investigational Site Number 250002', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '0440', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Investigational Site Number 578001', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}