Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 7:07 PM
Study NCT ID:
NCT00053092
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2003-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], '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': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}], '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': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2003-01-27', 'studyFirstSubmitQcDate': '2003-01-27', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate'}, {'measure': 'Time to disease progression'}, {'measure': 'Toxicity'}, {'measure': 'Overall survival'}]}, 'conditionsModule': {'keywords': ['contiguous stage II mantle cell lymphoma', 'noncontiguous stage II mantle cell lymphoma', 'stage I mantle cell lymphoma', 'stage III mantle cell lymphoma', 'stage IV mantle cell lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '19197729', 'type': 'RESULT', 'citation': 'Eve HE, Linch D, Qian W, Ross M, Seymour JF, Smith P, Stevens L, Rule SA. Toxicity of fludarabine and cyclophosphamide with or without rituximab as initial therapy for patients with previously untreated mantle cell lymphoma: results of a randomised phase II study. Leuk Lymphoma. 2009 Feb;50(2):211-5. doi: 10.1080/10428190802688509.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the response rates in patients with previously untreated mantle cell lymphoma treated with fludarabine and cyclophosphamide with or without rituximab.\n* Compare the time to disease progression in patients treated with these regimens.\n* Compare the toxicity of these regimens, in terms of adverse event profile, in these patients.\n* Compare the overall survival of patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms:\n\n* Arm I: Patients receive fludarabine IV\\* and cyclophosphamide IV\\* on days 1-3.\n* Arm II: Patients receive rituximab IV on day 1 and fludarabine IV\\* and cyclophosphamide IV\\* on days 2-4.\n\nNOTE: \\*In both arms, fludarabine and cyclophosphamide may be administered orally instead of IV.\n\nTreatment repeats every 28 days for 2-8 courses in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 56-82 patients (28-41 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed previously untreated mantle cell lymphoma requiring therapy\n\n * Any stage\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Bilirubin no greater than 2.5 times upper limit of normal (ULN)\\^\\*\n* Alkaline phosphatase no greater than 2.5 times ULN\\^\\*\n* Hepatitis B and hepatitis C negative NOTE: \\*Unless related to lymphoma\n\nRenal\n\n* Creatinine no greater than 2.5 times ULN\\^\\* NOTE: \\*Unless related to lymphoma\n\nOther\n\n* No other malignancy within the past 5 years except non-melanoma skin cancer or curatively resected carcinoma in situ of the cervix\n* No prior psychological illness or condition that would preclude study compliance\n* No known hypersensitivity to murine proteins\n* No concurrent uncontrolled medical conditions\n* No other illness that would severely limit life expectancy\n* HIV negative\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00053092', 'briefTitle': 'Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'CDR0000269136'}, 'secondaryIdInfos': [{'id': 'NCRI-LY05'}, {'id': 'ALLG-LY05'}, {'id': 'EU-20230'}, {'id': 'NCRILG-LY05'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL'}, {'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'fludarabine phosphate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Simon Rule, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Derriford Hospital'}, {'name': 'John Seymour, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Peter MacCallum Cancer Centre, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, 'collaborators': [{'name': 'Australasian Leukaemia and Lymphoma Group', 'class': 'OTHER'}]}}}