Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT00641095
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2008-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated 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': 'C024352', 'term': 'fludarabine'}], '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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2008-03-20', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of first administration of treatment until the date of death from any cause, assessed up to a maximum of 60 months', 'description': 'Overall survival - Time from date of first administration of treatment until death from any cause'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'From date of first treatment administration until the date of first documented progression or relapse, whichever came first, assessed up to a maximum of 60 months', 'description': 'Progression-free survival - Time from date of first administration of treatment to Disease Progression or replapse'}, {'measure': 'Toxicity - Number of patients with >=grade 3 toxicity', 'timeFrame': 'Within 30 days after last dose of treatment', 'description': 'Toxicity - Number of patients who suffer grade 3 or 4 toxicities'}, {'measure': 'Toxicity - Percentage of patients with >=grade 3 toxicity', 'timeFrame': 'Within 30 days after last dose of treatment', 'description': 'Toxicity - Percentage of patients who suffer grade 3 or 4 toxicities'}, {'measure': 'Tumor response duration', 'timeFrame': 'From date of first documentation of PR or CR until the date of first progression up to a maximum of 60 months', 'description': 'Tumor response duration - Time from Complete or Partial Response to disease progression'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, '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': '26611473', 'type': 'DERIVED', 'citation': 'Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. doi: 10.3324/haematol.2015.128710. Epub 2015 Nov 26.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/26611473', 'label': 'Abstract on Pubmed'}, {'url': 'http://www.haematologica.org/content/101/2/235.article-info', 'label': 'Publication in haematologica'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial is comparing how well fludarabine and cyclophosphamide work when given together with or without rituximab in treating patients with previously untreated mantle cell lymphoma.', 'detailedDescription': 'RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating mantle cell lymphoma.\n\nOUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive fludarabine phosphate IV or orally once daily and oral cyclophosphamide once daily on days 1-3. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive rituximab IV on day 1 and fludarabine phosphate IV or orally once daily and oral cyclophosphamide once daily on days 1-3. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo bone marrow and blood sample collection periodically for molecular studies. Samples are analyzed for morphology; sIgM, sIgD, CD19, CD20, CD5, CD10, CD23, bcl-1, bcl-6 via immunophenotyping and immunohistochemistry; and t(11,14) translocation via interphase fluorescence in situ hybridization (FISH) mutational analysis.\n\nAfter completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nThis trial follows on from the Phase II randomised study of fludarabine/cyclophosphamide combination with or without Rituximab in patients with untreated mantle cell lymphoma. ISRCTN number: NCT00053092\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed mantle cell lymphoma (MCL), meeting the following criteria:\n\n * Diagnosis confirmed by examination of representative material (lymph nodes or bone marrow) together with a typical immunophenotype CD5+, CD23-, sIgM, cyclin D1 nuclear positivity is desirable but not essential\n * Central review of histology will be performed on diagnostic material\n * Molecular or cytogenetic confirmation of diagnosis is not required\n* Previously untreated disease at any stage requiring therapy in the opinion of the treating physician\n\nPATIENT CHARACTERISTICS:\n\n* Life expectancy ≥ 3 months\n\n * Life expectancy not severely limited by other illness\n* Creatinine clearance ≥ 30 mL/min\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during study therapy\n* No known serological positivity for HBV, HCV, or HIV\n* No concurrent uncontrolled serious medical conditions\n* No severe impairment of renal or liver function (alkaline phosphatase, bilirubin or creatinine \\> 2.5 times upper limit of normal) not related to lymphoma\n* No known hypersensitivity to murine proteins\n* No prior malignancy in the past 5 years, except for nonmelanoma skin tumor or curatively resected carcinoma in situ of the uterine cervix\n* No history of a psychological illness or condition that, in the opinion of the investigator, may adversely affect compliance with study medication\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy'}, 'identificationModule': {'nctId': 'NCT00641095', 'acronym': 'MCLPIII', 'briefTitle': 'Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'UCL/06/052'}, 'secondaryIdInfos': [{'id': '2006-001965-41', 'type': 'EUDRACT_NUMBER'}, {'id': 'MREC-02/6/31', 'type': 'OTHER', 'domain': 'South West Multi-centre Research Ethics Committee'}, {'id': 'ISRCTN', 'type': 'REGISTRY', 'domain': 'NCT00641095'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fludarabine/Cyclophosphamide/Rituximab', 'description': 'Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Rituximab 375mgs/m2 day 1 iv infusion\n\nEvery 28 days', 'interventionNames': ['Biological: rituximab', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fludarabine/Cyclophosphamide', 'description': 'Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3\n\nEvery 28 days', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Fludarabine']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'description': 'concentrate for solution for infusion', 'armGroupLabels': ['Fludarabine/Cyclophosphamide/Rituximab']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Fludarabine/Cyclophosphamide', 'Fludarabine/Cyclophosphamide/Rituximab']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Film coated tablet', 'armGroupLabels': ['Fludarabine/Cyclophosphamide', 'Fludarabine/Cyclophosphamide/Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': 'TN24 0LZ', 'city': 'Ashford', 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'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}