Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-14 @ 9:12 PM
Study NCT ID:
NCT00116467
Status:
COMPLETED
Last Update Posted:
2007-12-24
First Post:
2005-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-18', 'studyFirstSubmitDate': '2005-06-29', 'studyFirstSubmitQcDate': '2005-06-29', 'lastUpdatePostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AML', 'Acute Myelogenous Leukemia', 'GVAX', 'Vaccine', 'Stem Cell Transplant', 'Autologous'], 'conditions': ['Acute Myelogenous Leukemia']}, 'referencesModule': {'references': [{'pmid': '19556425', 'type': 'DERIVED', 'citation': 'Borrello IM, Levitsky HI, Stock W, Sher D, Qin L, DeAngelo DJ, Alyea EP, Stone RM, Damon LE, Linker CA, Maslyar DJ, Hege KM. Granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting cellular immunotherapy in combination with autologous stem cell transplantation (ASCT) as postremission therapy for acute myeloid leukemia (AML). Blood. 2009 Aug 27;114(9):1736-45. doi: 10.1182/blood-2009-02-205278. Epub 2009 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Initial diagnosis of de novo AML with no preexisting hematologic dysplasia for more than 3 months.\n* No prior therapy except leukapheresis or less than 72 hours of hydroxyurea.\n\nExclusion Criteria:\n\n* Prior myelodysplastic disorder, or treatment-related leukemia.\n* Prior myeloproliferative disease.\n* Acute promyelocytic leukemia (APL).\n* Prior chemotherapy for a malignant or nonmalignant disorder.'}, 'identificationModule': {'nctId': 'NCT00116467', 'briefTitle': 'Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cell Genesys'}, 'officialTitle': 'Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line', 'orgStudyIdInfo': {'id': 'K-0009'}, 'secondaryIdInfos': [{'id': 'K-0009'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cell Genesys', 'class': 'INDUSTRY'}}}}