Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-30 @ 3:17 AM
Study NCT ID:
NCT01144403
Status:
TERMINATED
Last Update Posted:
2016-10-18
First Post:
2010-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'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'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was prematurely terminated with 8 participants enrolled, all of them are included into the statistical analyses.'}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 50 months', 'eventGroups': [{'id': 'EG000', 'title': 'Rituximab', 'description': 'Rituximab, 375 milligram per meter square (mg/m\\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).\n\nCyclophosphamide: as prescribed, 6 cycles\n\nFludarabine: as prescribed, 6 cycles\n\nMitoxantrone: as prescribed, 6 cycles\n\nRituximab \\[Mabthera/Rituxan\\]: 375 mg/m\\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Leucopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastric Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ascending Aorta Dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dermatitis Eczematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hepatitis Ag HBS+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vertiginous syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Supraventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Respiratory Virosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oral Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'ß2-microglobuline ↗', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'C- reactive protein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': 'Rituximab, 375 milligram per meter square (mg/m\\^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).\n\ncyclophosphamide: as prescribed, 6 cycles\n\nfludarabine: as prescribed, 6 cycles\n\nmitoxantrone: as prescribed, 6 cycles\n\nrituximab \\[Mabthera/Rituxan\\]: 375 mg/m\\^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 months (approximately)', 'description': 'Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all the participants who had received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': 'Rituximab, 375 milligram per meter square (mg/m\\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).\n\nCyclophosphamide: as prescribed, 6 cycles\n\nFludarabine: as prescribed, 6 cycles\n\nMitoxantrone: as prescribed, 6 cycles\n\nRituximab \\[Mabthera/Rituxan\\]: 375 mg/m\\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '927', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '2204.066'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of enrollment until death due to any cause (up to 50 months [approximately])', 'description': 'Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all the participants who had received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': 'Rituximab, 375 milligram per meter square (mg/m\\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).\n\nCyclophosphamide: as prescribed, 6 cycles\n\nFludarabine: as prescribed, 6 cycles\n\nMitoxantrone: as prescribed, 6 cycles\n\nRituximab \\[Mabthera/Rituxan\\]: 375 mg/m\\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '653', 'groupId': 'OG000', 'lowerLimit': '537.058', 'upperLimit': '768.942'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of enrollment until death due to any cause (up to 50 months [approximately])', 'description': 'PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all the participants who had received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participant With Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': 'Rituximab, 375 milligram per meter square (mg/m\\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).\n\nCyclophosphamide: as prescribed, 6 cycles\n\nFludarabine: as prescribed, 6 cycles\n\nMitoxantrone: as prescribed, 6 cycles\n\nRituximab \\[Mabthera/Rituxan\\]: 375 mg/m\\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 months (approximately)', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all the participants who had received at least one dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab', 'description': 'Rituximab, 375 milligram per meter square (mg/m\\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).\n\nCyclophosphamide: as prescribed, 6 cycles\n\nFludarabine: as prescribed, 6 cycles\n\nMitoxantrone: as prescribed, 6 cycles\n\nRituximab \\[Mabthera/Rituxan\\]: 375 mg/m\\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total 8 participants were enrolled from Romania.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab', 'description': 'Rituximab, 375 milligram per meter square (mg/m\\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).\n\nCyclophosphamide: as prescribed, 6 cycles\n\nFludarabine: as prescribed, 6 cycles\n\nMitoxantrone: as prescribed, 6 cycles\n\nRituximab \\[Mabthera/Rituxan\\]: 375 mg/m\\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.50', 'spread': '7.964', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2010-06-14', 'resultsFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2010-06-14', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-18', 'studyFirstPostDateStruct': {'date': '2010-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to 50 months (approximately)', 'description': 'Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the time of enrollment until death due to any cause (up to 50 months [approximately])', 'description': 'Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From the time of enrollment until death due to any cause (up to 50 months [approximately])', 'description': 'PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.'}, {'measure': 'Number of Participant With Adverse Event (AE)', 'timeFrame': 'Up to 50 months (approximately)', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.'}]}, 'conditionsModule': {'conditions': ['Diffuse Large B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m\\^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult participants, \\>/=18 years of age\n* untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation\n* known mantle cell lymphoma international prognostic index (MIPI) at diagnosis\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* adequate hematological, renal and hepatic function\n\nExclusion Criteria:\n\n* known hypersensitivity to murine proteins or chemotherapy regimen\n* previous first-line therapy\n* history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma\n* active infection\n* clinically significant cardiac disease\n* regular corticosteroid treatment in the 4 weeks prior to first dose of study drug'}, 'identificationModule': {'nctId': 'NCT01144403', 'briefTitle': 'A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'ML22489'}, 'secondaryIdInfos': [{'id': '2009-011433-27'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'description': 'Rituximab, 375 milligram per meter square (mg/m\\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: Mitoxantrone', 'Drug: Rituximab']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'as prescribed, 6 cycles', 'armGroupLabels': ['Rituximab']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'as prescribed, 6 cycles', 'armGroupLabels': ['Rituximab']}, {'name': 'Mitoxantrone', 'type': 'DRUG', 'description': 'as prescribed, 6 cycles', 'armGroupLabels': ['Rituximab']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera/Rituxan'], 'description': '375 mg/m\\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500326', 'city': 'Brasov', 'country': 'Romania', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '005098', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '030171', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400015', 'city': 'Cluj-Napoca', 'country': 'Romania', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '700111', 'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '540136', 'city': 'Târgu Mureş', 'country': 'Romania', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '300079', 'city': 'Timișoara', 'country': 'Romania', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}