Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-01 @ 1:49 AM
Study NCT ID:
NCT02110394
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2014-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia
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': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-04', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'Within 60-90 days after end of treatment'}], 'secondaryOutcomes': [{'measure': 'Adverse drug reactions', 'timeFrame': 'At all post-treatment visits (up to 30 days after end of treatment)'}, {'measure': 'Treatment Failure (TF)', 'timeFrame': 'Within 60-90 days after end of treatment'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': '60 months'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '60 months'}, {'measure': 'Relapse following complete or partial remission', 'timeFrame': '60 months'}, {'measure': 'Overall survival', 'timeFrame': '60 months'}, {'measure': 'Quality of Life of patients receiving Ribomustin therapy', 'timeFrame': 'At all post-treatment visits (up to 30 days after end of treatment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['observational', 'chronic lymphocytic leukemia', 'bendamustine'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with В-cell chronic lymphocytic leukemia under the care of a physician in the haematology/chemotherapy departments in 20-25 centers in the Russian Federation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin\n* Informed Consent Form for personal data handling signed by the program participant\n\nExclusion Criteria:\n\n* Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL\n* Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment\n* Contraindications for Ribomustin usage in accordance with product label'}, 'identificationModule': {'nctId': 'NCT02110394', 'acronym': 'NORMA', 'briefTitle': 'Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'RU-BEN-NI-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bendamustine and rituximab', 'interventionNames': ['Other: bendamustine', 'Other: rituximab']}], 'interventions': [{'name': 'bendamustine', 'type': 'OTHER', 'otherNames': ['Ribomustin'], 'description': 'Routine practice', 'armGroupLabels': ['bendamustine and rituximab']}, {'name': 'rituximab', 'type': 'OTHER', 'otherNames': ['Mabthera'], 'description': 'Routine practice', 'armGroupLabels': ['bendamustine and rituximab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buryatia', 'state': 'Ulan-Ude', 'country': 'Russia', 'facility': 'Republic Clinical Hospital n.a. N.A. Semashko'}, {'zip': '414056', 'city': 'Astrakhan', 'country': 'Russia', 'facility': 'Alexandro-Mariinskaia Regional Clinical Hospital/13', 'geoPoint': {'lat': 46.34968, 'lon': 48.04076}}, {'city': 'Cherepovets', 'country': 'Russia', 'facility': 'Vologda Reginal Clinical Hospital #2', 'geoPoint': {'lat': 59.13333, 'lon': 37.9}}, {'zip': '664079', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Irkutsk Regional Clinical Hospital/08', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'city': 'Kaliningrad', 'country': 'Russia', 'facility': 'Kaliningrad City Clinical Hospital', 'geoPoint': {'lat': 54.70639, 'lon': 20.51102}}, {'zip': '630009', 'city': 'Khabarovsk', 'country': 'Russia', 'facility': 'Regional Clinical Hospital#1/04', 'geoPoint': {'lat': 48.46204, 'lon': 135.0971}}, {'city': 'Khanty-Mansiysk', 'country': 'Russia', 'facility': 'District Cancer Center od Khanty -Mansiysk', 'geoPoint': {'lat': 61.00187, 'lon': 69.02728}}, {'zip': '105203', 'city': 'Moscow', 'country': 'Russia', 'facility': 'National Medical Surgical Center n.a.N.I.Pirogov/15', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'RONC n.a.N.N.Blokhin/21', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129128', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Сentral Clinical Hospital n.a.N.A.Semashko/20', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Central Clinical Hospital of Department of Presidential Affairs', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '183047', 'city': 'Murmansk', 'country': 'Russia', 'facility': 'Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31', 'geoPoint': {'lat': 68.96778, 'lon': 33.09922}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '249036', 'city': 'Obninsk', 'country': 'Russia', 'facility': 'Medical Radiology Scientific Center/23', 'geoPoint': {'lat': 55.10993, 'lon': 36.61238}}, {'city': 'Omsk', 'country': 'Russia', 'facility': 'Omsk Regional Clinical Hospital', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '460000', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'Orenburg State Medical Academy/011', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'city': 'Perm', 'country': 'Russia', 'facility': 'Perm regional hospital', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'zip': '185019', 'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'city': 'Pskov', 'country': 'Russia', 'facility': 'Pskov Regional Clinical Hospital', 'geoPoint': {'lat': 57.81922, 'lon': 28.33181}}, {'zip': '344037', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Rostov Scientific Research Oncology Institution/03', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Site 70001 Private Practice', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Military-Medical Academy n.a. 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V.I.Razumovskiy', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '214025', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Road Clinical Hospital on Smolensk station OAO RZhD/12', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '167904', 'city': 'Syktyvkar', 'country': 'Russia', 'facility': 'Komi Republican Oncology Dispensary /01', 'geoPoint': {'lat': 61.66393, 'lon': 50.8163}}, {'zip': '300053', 'city': 'Tula', 'country': 'Russia', 'facility': 'Tula Regional Clinical Hospital/07', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'zip': '625023', 'city': 'Tyumen', 'country': 'Russia', 'facility': 'Tyumen Regional Clinical Hospital#1/27', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'zip': '432063', 'city': 'Ulyanovsk', 'country': 'Russia', 'facility': 'Regional Clinical Hospital/26', 'geoPoint': {'lat': 54.32824, 'lon': 48.38657}}, {'zip': '400138', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Volgograd Regional Clinical Oncology Dispensary#1/25', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'city': 'Vologda', 'country': 'Russia', 'facility': 'Vologda Regional Clinical Hospital', 'geoPoint': {'lat': 59.2239, 'lon': 39.88398}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Yekaterinburg City Hospital #7', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Yekaterinburg Regional Clinical Hospital #1', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Clinical Study Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}