Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 11:40 AM
Study NCT ID:
NCT00528333
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2007-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C477390', 'term': 'lintuzumab'}, {'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'dispFirstSubmitDate': '2011-10-07', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-17', 'studyFirstSubmitDate': '2007-09-10', 'dispFirstSubmitQcDate': '2011-10-07', 'studyFirstSubmitQcDate': '2007-09-11', 'dispFirstPostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics', 'timeFrame': '13 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lintuzumab', 'Antigens, CD33', 'Antibodies, Monoclonal', 'Leukemia, Myeloid, Acute', 'Hematologic Diseases', 'Leukemia'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '22801961', 'type': 'RESULT', 'citation': 'Sekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL, Jurcic JG. Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013 Jan;98(1):119-28. doi: 10.3324/haematol.2012.066613. Epub 2012 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.\n* After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.\n* At least 20% blasts in blood or marrow.\n* Must have a minimum of 50% leukemic blasts that express CD33.\n* ECOG performance status score of 0 to 2.\n* WBC less than 30,000/µL\n\nExclusion Criteria:\n\n* No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.\n* No other active systemic malignancies treated with chemotherapy within the last 12 months.\n* Must not have received previous chemotherapy (except hydroxyurea) for AML.\n* Must not have significantly abnormal kidney or liver disease.\n* Must not have known human immunodeficiency virus (HIV).'}, 'identificationModule': {'nctId': 'NCT00528333', 'briefTitle': 'A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seagen Inc.'}, 'officialTitle': 'A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML', 'orgStudyIdInfo': {'id': 'SG033-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lintuzumab plus low dose cytarabine', 'interventionNames': ['Drug: Lintuzumab (SGN-33)', 'Drug: Low dose cytarabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Placebo plus low dose cytarabine', 'interventionNames': ['Drug: Low dose cytarabine', 'Drug: Placebo']}], 'interventions': [{'name': 'Lintuzumab (SGN-33)', 'type': 'DRUG', 'otherNames': ['SGN-33'], 'description': '600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.', 'armGroupLabels': ['1']}, {'name': 'Low dose cytarabine', 'type': 'DRUG', 'otherNames': ['Ara-C, Cytosar'], 'description': '20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Tower Cancer Research Foundation', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Memorial Hospital', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kenmar Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1678', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94523', 'city': 'Pleasant Hill', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Cancer Research Group', 'geoPoint': {'lat': 37.94798, 'lon': -122.0608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakeland Regional Cancer Center', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center & Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology-Hematology Associates', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University, Breslin Cancer Center', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Billings Clinic Cancer Research', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Northshore University Hospital, Monter Cancer Center', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Pennsylvania Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gunderson Clinic', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Eric Sievers, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seagen Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seagen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}