Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00517218
Status:
WITHDRAWN
Last Update Posted:
2008-02-11
First Post:
2007-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C408162', 'term': 'oblimersen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2009-06'}, 'lastUpdateSubmitDate': '2008-02-07', 'studyFirstSubmitDate': '2007-08-14', 'studyFirstSubmitQcDate': '2007-08-15', 'lastUpdatePostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Evaluate the Effect of Genasense on the Efficacy/Safety of Rituximab/Fludarabine Treatment in Untreated Subjects With Chronic Lymphocyctic Leukemia'], 'conditions': ['Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with CLL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV)\n* Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL\n* Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines\n* Eastern Cooperative Oncology Group Performance Status \\< 2\n* Adequate organ function determined , 14 days prior to the first dose of study medication\n\nExclusion Criteria:\n\n* Absolute Lymphocyte count \\> 100,000/uL\n* Prior chemotherapy or other therapy for CLL, including allogeneic transplant\n* Less than 3 weeks from any prior major surgery at the time of informed consent\n* Failure to recover from any serious adverse effect of surgery\n* History of autoimmune hemolytic anemia or autoimmune thrombocytopenia\n* Active serious infection requiring systemic anti-infective therapy'}, 'identificationModule': {'nctId': 'NCT00517218', 'briefTitle': 'This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genta Incorporated'}, 'officialTitle': 'A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'GL305'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Genasense® (, oblimersen sodium G3139)', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genta Incorporated', 'class': 'INDUSTRY'}}}}