Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT01224093
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Efficacy (Response rate, duration of response, progression-free survival)', 'timeFrame': '3 years'}, {'measure': 'Chronic lymphocytic leukaemia (CLL) Comorboid Scale', 'timeFrame': '3 years'}, {'measure': 'Quality-adjusted survival analysis (Q-TWIST methodology)', 'timeFrame': '3 years'}]}, 'conditionsModule': {'conditions': ['Lymphocytic Leukemia, Chronic']}, 'descriptionModule': {'briefSummary': 'This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with B cell-lineage chronic lymphocytic leukaemia (B-CLL)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* B cell-lineage chronic lymphocytic leukaemia (B-CLL)\n* Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC\n* Informed consent to data collection\n\nExclusion Criteria:\n\n* Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study\n* Any other tumour disease'}, 'identificationModule': {'nctId': 'NCT01224093', 'briefTitle': 'An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)', 'orgStudyIdInfo': {'id': 'ML25372'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First line', 'interventionNames': ['Drug: Chemotherapy', 'Drug: rituximab [MabThera/Rituxan]']}, {'label': 'Relapsed/refractory', 'interventionNames': ['Drug: Chemotherapy', 'Drug: rituximab [MabThera/Rituxan]']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['First line', 'Relapsed/refractory']}, {'name': 'rituximab [MabThera/Rituxan]', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['First line', 'Relapsed/refractory']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '03010', 'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '03203', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '04009', 'city': 'Almería', 'state': 'Almeria', 'country': 'Spain', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '07014', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '08915', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': 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