Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-28 @ 12:13 PM
Study NCT ID:
NCT02072967
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2014-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'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'}, {'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': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2014-02-25', 'studyFirstSubmitQcDate': '2014-02-25', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '90 days post-treatment'}], 'secondaryOutcomes': [{'measure': 'Adverse drug reactions', 'timeFrame': 'up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapsed', 'Refractory', 'Non-Hodgkin Lymphoma', 'Bendamustine'], 'conditions': ['Lymphoma, Non-Hodgkin']}, 'descriptionModule': {'briefSummary': "Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the second line therapy of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma with planned combined Ribomustin and rituximab therapy", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Doctor's decision to prescribe Ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma (iNHL)\n* Informed Consent Form for personal data handling signed by the program participant, authorized by the Independent Ethics Committee\n* Eastern Cooperative Oncology Group (ECOG) status \\< 2.\n* Confirmed relapse or disease progression of B-cell CD20+ Non-Hodgkin's Lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of iNHL treatment\n* Patients with relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma with current or planned Ribomustin and rituximab combined therapy with following rituximab maintenance therapy\n\nExclusion Criteria:\n\n* Indolent Non-Hodgkin's Lymphoma transformation\n* Lymphoma with central nervous system (CNS) involvement\n* Presence of second malignant tumor.\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\n* Contradictions for rituximab usage in accordance with product label"}, 'identificationModule': {'nctId': 'NCT02072967', 'briefTitle': "Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': "Observational Program for Evaluation of Ribomustin and Rituximab Combined Therapy With Following Rituximab Maintenance of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'RU-BEN-NI-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ribomustin and rituximab', 'interventionNames': ['Other: Ribomustin', 'Other: rituximab']}], 'interventions': [{'name': 'Ribomustin', 'type': 'OTHER', 'otherNames': ['bendamustine'], 'description': 'Routine practice', 'armGroupLabels': ['Ribomustin and rituximab']}, {'name': 'rituximab', 'type': 'OTHER', 'otherNames': ['Mabthera'], 'description': 'Routine practice', 'armGroupLabels': ['Ribomustin and rituximab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barnaul', 'country': 'Russia', 'facility': 'City Clinical Hospital #8', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '454087', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Chelyabinsk Regional Oncology Dispensary/15', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Cherepovets', 'country': 'Russia', 'facility': 'Vologda Regional Clinical Hospital #2', 'geoPoint': {'lat': 59.13333, 'lon': 37.9}}, {'zip': '664035', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Regional Oncology Dispensary/35', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '664079', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Irkutsk Regional Сlinical Hospital/31', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '248007', 'city': 'Kaluga', 'country': 'Russia', 'facility': 'Kaluga Regional Clinical Hospital/02', 'geoPoint': {'lat': 54.53063, 'lon': 36.27}}, {'city': 'Khanty-Mansiysk', 'country': 'Russia', 'facility': 'District Cancer center od Khanty -Mansiysk', 'geoPoint': {'lat': 61.00187, 'lon': 69.02728}}, {'zip': '660003', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'City Сlinical Hospital#7/25', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '660022', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Regional Сlinical Hospital/12', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '385017', 'city': 'Maykop', 'country': 'Russia', 'facility': 'Adygei Regional Clinical Oncology Dispensary/11', 'geoPoint': {'lat': 44.60789, 'lon': 40.10242}}, {'zip': '105203', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Scientific Medical Surgical Center n.a.I.V.Pyrogov/17', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '105229', 'city': 'Moscow', 'country': 'Russia', 'facility': 'European Medical Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'RONC n.a.N.N.Blokhin/18', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129128', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Сentral Clinical Hospital n.a. Semashko N.A./30', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '443099', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37', '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}}, {'zip': '603003', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Municipal Сlinical Hospital № 12/20', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630087', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Novosibirsk State Regional Clinical Hospital/23', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '249036', 'city': 'Obninsk', 'country': 'Russia', 'facility': 'Medical Radiology Scientific Center/38', 'geoPoint': {'lat': 55.10993, 'lon': 36.61238}}, {'zip': '644111', 'city': 'Omsk', 'country': 'Russia', 'facility': 'Omsk Regional Clinical Hospital/40', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '644112', 'city': 'Omsk', 'country': 'Russia', 'facility': 'City Сlinical Hospital#1 n.a.Kabanov A.N./13', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '460000', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'Orenburg State Medical Academy/05', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '344037', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Rostov Scientific Research Oncology Institution/01', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Сlinical Oncological Dispensary/22', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197110', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Сlinical Hospital#31/08', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Military-Medical Academy n.a. Kirova', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Scientific Research Oncological Institution n.a. Petrov N.N./29', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443099', 'city': 'Samara', 'country': 'Russia', 'facility': "Samara State Medical University' Clinics/36", 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '214025', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Road Clinical Hospital on Rostov-Main Station OAO RZhD/06', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'Surgut', 'country': 'Russia', 'facility': 'Surgut Regional Clinical Hospital', 'geoPoint': {'lat': 61.25757, 'lon': 73.41775}}, {'zip': '300053', 'city': 'Tula', 'country': 'Russia', 'facility': 'Tula Regional Clinical Hospital/21', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'zip': '400138', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Volgograd Regional Clinical Oncology Dispensary#1/10', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '160002', 'city': 'Vologda', 'country': 'Russia', 'facility': 'Vologda Regional Clinical Hospital/39', 'geoPoint': {'lat': 59.2239, 'lon': 39.88398}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Yekaterinburg Regional Clinical Hospital #1', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '693010', 'city': 'Yuzhno-Sakhalinsk', 'country': 'Russia', 'facility': 'Sakhalin Regional Oncology Dispensary/32', 'geoPoint': {'lat': 46.9543, 'lon': 142.73559}}], 'overallOfficials': [{'name': 'Clinical Study Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}