Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT00260832
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2005-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Decitabine in Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Serbia and Montenegro']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'D012847', 'term': 'Single Person'}], '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'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D017533', 'term': 'Marital Status'}, {'id': 'D005191', 'term': 'Family Characteristics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esi_medinfo@eisai.com', 'phone': '1-888-274-2378', 'title': 'Eisai Medical Information', 'organization': 'Eisai Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cytarabine or Supportive Care', 'description': "Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)", 'otherNumAtRisk': 237, 'otherNumAffected': 231, 'seriousNumAtRisk': 237, 'seriousNumAffected': 162}, {'id': 'EG001', 'title': 'Dacogen (Decitabine) Only', 'description': '20 mg/m\\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.', 'otherNumAtRisk': 238, 'otherNumAffected': 237, 'seriousNumAtRisk': 238, 'seriousNumAffected': 190}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 114}], 'organSystem': 'General disorders'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 55}], 'organSystem': 'General disorders'}, {'term': 'Peripheral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 50}], 'organSystem': 'General disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 58}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 35}], 'organSystem': 'Infections and infestations'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 25}], 'organSystem': 'Infections and infestations'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 106}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 97}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 79}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 48}], 'organSystem': 'Infections and infestations'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 15}], 'organSystem': 'Infections and infestations'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 15}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 9}], 'organSystem': 'Infections and infestations'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 27}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 23}], 'organSystem': 'General disorders'}, {'term': 'General Physical Health Deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 15}], 'organSystem': 'General disorders'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cytarabine or Supportive Care', 'description': "Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)"}, {'id': 'OG001', 'title': 'Dacogen (Decitabine) Only', 'description': '20 mg/m\\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '6.3'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '9.2'}]}]}], 'analyses': [{'pValue': '0.1079', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'The primary treatment comparison was based on two sided long-rank test stratified by age, cytogenetic risk, ECOG performance status', 'statisticalMethod': 'Kaplan-Meier', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.', 'description': 'The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for all efficacy analyses was the Intent-to-treat (ITT) population defined as all subjects randomly allocated to a treatment arm.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cytarabine or Supportive Care', 'description': "Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)"}, {'id': 'OG001', 'title': 'Dacogen (Decitabine) Only', 'description': '20 mg/m\\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '1.40', 'ciUpperLimit': '4.78', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)', 'description': 'Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (\\<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (\\>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (\\>)1,000 per microliter (/mcL), platelet count of \\>=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count \\>=100,000/mcL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for all efficacy analyses was the ITT population defined as all participant randomly allocated to a treatment arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cytarabine or Supportive Care', 'description': "Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)"}, {'id': 'FG001', 'title': 'Dacogen (Decitabine) Only', 'description': '20 mg/m\\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '242'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'At study completion, these subjects chose to remain on treatment', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'At study completion, these subjects chose to remain on treatment', 'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '211'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was recruited at 65 centers in 12 countries during the period of 2006 to 2009.', 'preAssignmentDetails': "Prior to randomization, subjects indicated their preference for treatment, with physician's advice, or either cytarabine or supportive care in the event they were randomized to Arm A."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '485', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cytarabine or Supportive Care', 'description': "Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)"}, {'id': 'BG001', 'title': 'Dacogen (Decitabine) Only', 'description': '20 mg/m\\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.53', 'spread': '5.67', 'groupId': 'BG000'}, {'value': '73.14', 'spread': '5.24', 'groupId': 'BG001'}, {'value': '73.34', 'spread': '5.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2005-12-01', 'resultsFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2005-12-01', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-16', 'studyFirstPostDateStruct': {'date': '2005-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.', 'timeFrame': 'The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.', 'description': 'The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)', 'timeFrame': 'Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)', 'description': 'Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (\\<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (\\>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (\\>)1,000 per microliter (/mcL), platelet count of \\>=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count \\>=100,000/mcL.'}]}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia', 'Dacogen', 'Decitabine', 'Poor or intermediate-risk cytogenetics'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '24498872', 'type': 'DERIVED', 'citation': 'Mayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must have diagnosed acute myeloid leukemia.\n2. Must have a life expectancy of at least 12 weeks.\n3. Must sign informed consent.\n\nExclusion Criteria:\n\n1. Must not have acute promyelocytic leukemia (M3 classification)\n2. Must not have any other active systemic malignancies.\n3. Must not have inaspirable bone marrow.\n4. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.\n5. Must not have chronic respiratory disease that requires continuous oxygen use.\n6. Must not have received any experimental drug within 4 weeks before randomization.\n7. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.\n8. Must not have known HIV.'}, 'identificationModule': {'nctId': 'NCT00260832', 'briefTitle': 'Trial of Decitabine in Patients With Acute Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': "Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia", 'orgStudyIdInfo': {'id': 'DACO-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': "Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.)", 'interventionNames': ['Drug: Cytarabine or Supportive Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Dacogen (decitabine) only']}], 'interventions': [{'name': 'Cytarabine or Supportive Care', 'type': 'DRUG', 'description': "Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\\^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)", 'armGroupLabels': ['A']}, {'name': 'Dacogen (decitabine) only', 'type': 'DRUG', 'otherNames': ['decitabine'], 'description': '20mg/m\\^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United 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