Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT00003605
Status:
WITHDRAWN
Last Update Posted:
2015-08-19
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rituximab Plus Cyclophosphamide in Treating Patients With Indolent Stage III or Stage IV Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], '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': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], '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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no patient accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-08-03', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Waldenstrom macroglobulinemia', 'stage III grade 1 follicular lymphoma', 'stage III grade 2 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage III adult diffuse small cleaved cell lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'stage IV adult diffuse small cleaved cell lymphoma', 'stage III small lymphocytic lymphoma', 'stage III marginal zone lymphoma', 'stage IV small lymphocytic lymphoma', 'stage IV marginal zone lymphoma', 'extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue', 'nodal marginal zone B-cell lymphoma', 'splenic marginal zone lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy and monoclonal antibody therapy may kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of rituximab plus cyclophosphamide in treating patients who have indolent stage III or stage IV non-Hodgkin's lymphoma.", 'detailedDescription': 'OBJECTIVES: I. Determine the toxicity associated with cyclophosphamide and rituximab (IDEC-C2B8 monoclonal antibody) as first line treatment in patients with stage III or IV indolent B-cell lymphoma. II. Determine the objective tumor response rate and duration of response associated with this first line treatment in these patients. III. Determine the failure-free and overall survival for these patients. IV. Compare the response rate and survival rates for patients with indolent lymphoma who were treated with this treatment as the first systemic therapy for their disease with response rates and survival observed for similar patients treated in published trials. V. Determine the quality of life associated with this treatment in this patient population.\n\nOUTLINE: This is an open label study. Patients receive oral cyclophosphamide daily and rituximab (IDEC-C2B8 monoclonal antibody) IV on days 1, 8, 15, and 22 for the first 4-week course. Patients then receive oral cyclophosphamide daily and rituximab IV monthly until 2 months beyond maximum response. Patients are treated for at least 6 months but no more than 18 months in the absence of disease progression. Patients are followed every 3 months for 2 years, then every 6 months for the next 2 years, and then annually for up to 10 years.\n\nPROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV indolent B-cell lymphoma Diffuse small cleaved cell lymphoma Follicular small cleaved cell lymphoma Follicular mixed cell lymphoma Follicular large cell lymphoma At least 1 lymph node or visceral lesion at least 2 cm in diameter\n\nPATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: No active infection No concurrent life threatening disease Not pregnant Effective contraception required of all fertile patients\n\nPRIOR CONCURRENT THERAPY: No prior therapy for lymphoma'}, 'identificationModule': {'nctId': 'NCT00003605', 'briefTitle': "Rituximab Plus Cyclophosphamide in Treating Patients With Indolent Stage III or Stage IV Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Hoag Memorial Hospital Presbyterian'}, 'officialTitle': 'Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma', 'orgStudyIdInfo': {'id': 'CDR0000066680'}, 'secondaryIdInfos': [{'id': 'CBRG-9801'}, {'id': 'GENENTECH-CBRG-9801'}, {'id': 'NBSG-9801'}, {'id': 'NCI-V98-1483'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL'}, {'name': 'cyclophosphamide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92658', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '47402', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Bloomington Hospital', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'facility': 'St. Joseph Regional Cancer Center', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}], 'overallOfficials': [{'name': 'Robert O. Dillman, MD, FACP', 'role': 'STUDY_CHAIR', 'affiliation': 'Cancer Biotherapy Research Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoag Memorial Hospital Presbyterian', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Biotherapy Research Group', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Robert O. Dillman, MD', 'oldOrganization': 'Hoag Memorial Hospital Presbyterian'}}}}