Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT00204659
Status:
COMPLETED
Last Update Posted:
2008-10-20
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535648', 'term': 'Familial primary gastric lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-17', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate', 'timeFrame': 'at end of chemo-immunotherapy'}, {'measure': 'Progression-free survival', 'timeFrame': 'at 2 and 5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'at 2 and 5 years'}, {'measure': 'Toxicity', 'timeFrame': 'after chemo-immunotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rituximab', 'CHOP', 'DLBCL', 'gastric lymphoma'], 'conditions': ['Primary Gastric Diffuse-Large B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years\n* Histologically confirmed primary gastric CD20+ DLBCL\n* Written informed consent\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Secondary aggressive Non-Hodgkin's lymphoma involving the gastric area\n* HIV positive patients\n* Severe organ dysfunction\n* Life expectancy of less than 3 months"}, 'identificationModule': {'nctId': 'NCT00204659', 'briefTitle': "Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': "Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': '64-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rituximab + CHOP chemotherapy', 'type': 'DRUG', 'otherNames': ['MabThera'], 'description': 'standard Rituximab + CHOP chemo-immunotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Zentralklinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'University of Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Reutlingen', 'country': 'Germany', 'facility': 'Klinikum Reutlingen', 'geoPoint': {'lat': 48.49144, 'lon': 9.20427}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tubingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '78050', 'city': 'Villingen-Schwenningen', 'country': 'Germany', 'facility': 'Schwarzwald-Baar Clinic', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}], 'overallOfficials': [{'name': 'Wolfram Brugger, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Wolfram Brugger, M.D.', 'oldOrganization': 'Schwarzwald-Baar Clinic, Academic Teaching Hospital, Univ. Freiburg'}}}}