Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-28 @ 4:47 AM
Study NCT ID:
NCT00774332
Status:
UNKNOWN
Last Update Posted:
2008-10-17
First Post:
2008-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C039323', 'term': 'ANAVACYM protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-15', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of complete remission, disease-free survival, overall survival, toxicities', 'timeFrame': '2009'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL', 'detailedDescription': 'The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with relapsed/resistant acute lymphoblastic leukemia\n* Patients must be between 15 and 65 years of age.\n* Estimated life expectancy of more than 3 months\n* ECOG performance status of 2 or lower, Karnofsky scale \\> 60 (see appendix I)\n* Adequate cardiac function (EF\\>45%) on echocardiogram or MUGA scan\n* Adequate kidney function (estimated Ccr \\>50 ml/min)\n\nExclusion Criteria:\n\n* Patients with CNS involvement of leukemic blasts will not be excluded.\n* Patients with extramedullary relapse(s) only will be excluded.'}, 'identificationModule': {'nctId': 'NCT00774332', 'briefTitle': 'A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL', 'organization': {'class': 'NETWORK', 'fullName': 'Cooperative Study Group A for Hematology'}, 'officialTitle': 'A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL', 'orgStudyIdInfo': {'id': 'C-011'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CODOX-M', 'type': 'DRUG', 'description': 'Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-Hee Lee, Doctor', 'role': 'CONTACT', 'email': 'jhleecr@amc.seoul.kr', 'phone': '82-2-3010-5794'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jung-Hee Lee, doctor', 'role': 'CONTACT', 'email': 'jhleecr@amc.seoul.kr', 'phone': '82-2-3010-5794'}], 'overallOfficials': [{'name': 'Jung-Hee Lee, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cooperative Study Group A for Hematology', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Yeungnam University College of Medicine', 'oldOrganization': 'Yeungnam University College of Medicine'}}}}