Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT01247493
Status:
COMPLETED
Last Update Posted:
2010-11-24
First Post:
2010-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060828', 'term': 'Induction Chemotherapy'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D015255', 'term': 'Idarubicin'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012074', 'term': 'Remission Induction'}, {'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': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-23', 'studyFirstSubmitDate': '2010-11-17', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate', 'description': 'Rate of complete remssion (CR) after two cycles of m-FLAI induction'}], 'secondaryOutcomes': [{'measure': 'Rate of serious adverse events (SAE)', 'description': 'Number of patients dying from SAE related to m-FLAI induction'}, {'measure': 'Event Free Survival', 'description': 'Event free survival defined as a period from study enrollment to death by from cause or relapse of disease after complete remission'}, {'measure': 'overall survival', 'description': 'Overall survival defined as a period from study enrollment to death from any cause'}, {'measure': 'Predictive factors for Complete remission', 'description': 'Compare complete remission rate according to existence of specific chromosome abnormality and Charlson comorbidity index to evaluate predicative impact of these factors.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fludarabine', 'AML', 'Efficacy', 'tolerability'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '23077109', 'type': 'DERIVED', 'citation': 'Kim I, Koh Y, Yoon SS, Park S, Kim BK, Kim DY, Lee JH, Lee KH, Cheong JW, Lee HK, Kim SH, Kim H, Joo YD, Lee SM, Won JH, Park SK, Hong DS, Kim SH, Sohn SK, Kim CS, Park E, Kim MK, Park MR, Lee JH, Min YH; Korean Society of Hematology AML/MDS working party. Fludarabine, cytarabine, and attenuated-dose idarubicin (m-FLAI) combination therapy for elderly acute myeloid leukemia patients. Am J Hematol. 2013 Jan;88(1):10-5. doi: 10.1002/ajh.23337. Epub 2012 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute myeloid leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previously untreated AML (excluding acute promyelocytic leukemia)\n* age greater than 60 years old\n* ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2\n* adequate hepatic/ renal/ cardiac function\n\nExclusion Criteria:\n\n* acute promyelocytic leukemia\n* significant cardiac disease\n* combined non-hematologic malignancy\n* aleukemic leukemia (only granulocytic sarcoma)\n* CNS (Central Nervous system) involvement\n* significant comorbidity/ uncontrollable bleeding tendency'}, 'identificationModule': {'nctId': 'NCT01247493', 'acronym': 'm-FLAI', 'briefTitle': 'Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)', 'orgStudyIdInfo': {'id': 'H-0704-029-205'}}, 'armsInterventionsModule': {'interventions': [{'name': 'induction chemotherapy (fludarabine, cytarabine, idarubicin)', 'type': 'DRUG', 'description': 'fludarabine, cytarabine, idarubicin'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Inho Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kim, Inho professor', 'oldOrganization': 'SeoulNUH'}}}}