Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01224769
Status:
COMPLETED
Last Update Posted:
2010-10-21
First Post:
2010-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-20', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': 'within 1 month after end of treatment'}], 'secondaryOutcomes': [{'measure': 'grade III and IV (NCI Common Toxicity Criteria) adverse events', 'timeFrame': 'within 1 month after end of treatment'}, {'measure': 'prognostic factors', 'timeFrame': 'within 1 month after end of treatment'}, {'measure': 'progression free survival', 'timeFrame': 'within 1 month after end of treatment'}, {'measure': 'overall survival', 'timeFrame': 'within 1 month after end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory Chronic Lymphoproliferative Disorders']}, 'descriptionModule': {'briefSummary': 'This retrospective study collects and evaluates the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with relapsed or refractory chronic lymphoproliferative disorders treated with bendamustine +/- rituximab', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with relapsed or refractory chronic lymphoproliferative disorders\n* salvage treatment with bendamustine +/- rituximab\n* age ≥ 18 years\n\nExclusion Criteria:\n\n* previous treatment with bendamustine'}, 'identificationModule': {'nctId': 'NCT01224769', 'briefTitle': 'Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Italiano Studio Linfomi'}, 'officialTitle': 'A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, as Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders', 'orgStudyIdInfo': {'id': 'RETRO-BENDA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bendamustine +/- rituximab', 'interventionNames': ['Drug: bendamustine +/- rituximab']}], 'interventions': [{'name': 'bendamustine +/- rituximab', 'type': 'DRUG', 'armGroupLabels': ['bendamustine +/- rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41124', 'city': 'Modena', 'country': 'Italy', 'facility': 'Gruppo Italiano Studio Linfomi', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'Emilio Iannitto, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gruppo Italiano Studio Linfomi'}, {'name': 'Fortunato Morabito, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gruppo Italiano Studio Linfomi'}, {'name': 'Stefano Luminari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gruppo Italiano Studio Linfomi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano Studio Linfomi', 'class': 'OTHER'}}}}