Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-28 @ 5:48 PM
Study NCT ID:
NCT01423032
Status:
COMPLETED
Last Update Posted:
2011-08-25
First Post:
2011-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D012008', 'term': 'Recurrence'}], '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': 'C024352', 'term': 'fludarabine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-24', 'studyFirstSubmitDate': '2011-08-19', 'studyFirstSubmitQcDate': '2011-08-24', 'lastUpdatePostDateStruct': {'date': '2011-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': 'the patients were followed on average for 36 months', 'description': 'individual time-frame up to max. follow-up (Kaplan-Meier estimation)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['relapsed'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine.\n\nPatients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* histologically or immunologically confirmed chronic B-cell leukemia\n* refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen\n* disease stage II-IV according to Rai or B/C according to Binet staging system, respectively\n* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better\n* negative pregnancy test/ adequate method of contraception\n\nExclusion Criteria:\n\n* T-CLL, PLL (prolymphocytic leukemia)\n* presence of Richter's transformation\n* first-line treatment containing either fludarabine or bendamustine\n* acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin \\> 5mg/dl), renal system (creatinine \\> 2 mg/dl), or metabolic disorders\n* secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)"}, 'identificationModule': {'nctId': 'NCT01423032', 'briefTitle': 'Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)', 'organization': {'class': 'OTHER', 'fullName': 'WiSP Wissenschaftlicher Service Pharma GmbH'}, 'officialTitle': 'Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV', 'orgStudyIdInfo': {'id': 'WISP_RI05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bendamustine', 'interventionNames': ['Drug: bendamustine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fludarabine', 'interventionNames': ['Drug: Fludarabine']}], 'interventions': [{'name': 'bendamustine', 'type': 'DRUG', 'description': '100 mg/m² iv, day 1+2, q4w', 'armGroupLabels': ['Bendamustine']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': '25 mg/m² iv, days 1-5, q4w', 'armGroupLabels': ['Fludarabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-51375', 'city': 'Leverkusen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Prof. Dr. Norbert Niederle', 'geoPoint': {'lat': 51.0303, 'lon': 6.98432}}], 'overallOfficials': [{'name': 'Norbert Niederle, Prof, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Med. Klinik III, Klinikum Leverkusen gGmbH, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WiSP Wissenschaftlicher Service Pharma GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinikum Leverkusen gGmbH', 'class': 'UNKNOWN'}, {'name': 'ribosepharm GmbH', 'class': 'UNKNOWN'}, {'name': 'Mundipharma Research GmbH & Co KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}