Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-28 @ 4:30 AM
Study NCT ID:
NCT00909168
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2009-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive 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': 'D015255', 'term': 'Idarubicin'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D000079982', 'term': 'Gemtuzumab'}], 'ancestors': [{'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'}, {'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': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-05', 'studyFirstSubmitDate': '2009-05-26', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.', 'timeFrame': 'one year'}, {'measure': 'RFS, DFS and OS.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.', 'timeFrame': 'one year'}, {'measure': 'Evaluation of prognostic clinical relevance of biological features at onset.', 'timeFrame': 'one year'}, {'measure': 'Feasibility and outcome of consolidation with BMT.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Induction chemotherapy', 'Fludarabine', 'Gemtuzumab Ozogamicin'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '29396857', 'type': 'DERIVED', 'citation': 'Candoni A, Papayannidis C, Martinelli G, Simeone E, Gottardi M, Iacobucci I, Gherlinzoni F, Visani G, Baccarani M, Fanin R. Flai (fludarabine, cytarabine, idarubicin) plus low-dose Gemtuzumab Ozogamicin as induction therapy in CD33-positive AML: Final results and long term outcome of a phase II multicenter clinical trial. Am J Hematol. 2018 May;93(5):655-663. doi: 10.1002/ajh.25057. Epub 2018 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.\n\nTrial is based on:\n\n* INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).\n* CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC)\n* INTENSIFICATION: Allo-BMT, ASCT\n* MAINTENANCE: AraC\n\n a) Primary endpoints:\n* Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.\n* RFS, DFS and OS.\n\n b) Secondary endpoints:\n* Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.\n* Evaluation of prognostic clinical relevance of biological features at onset.\n* Feasibility and outcome of consolidation with BMT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years.\n* WHO PS grade 0-2 (Appendix B) or Karnofsky \\> 70.\n* AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy\n* All FAB subtypes except M3.\n* CD33 positivity (\\> 20%). It is mandatory to perform an immunotyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor.\n* Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS).\n* Adequate renal and liver function, i.e., creatinine \\< 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.\n* Written informed consent\n\nExclusion Criteria:\n\n* Blast crisis of chronic myeloid leukemia.\n* AML supervening after other myeloproliferative diseases.\n* AML de novo or secondary previously pretreated.\n* Concomitant malignant disease.\n* Active central nervous system (CNS) leukemia.\n* Active uncontrolled infection \\[NB severe systemic infection should be excluded\\].\n* Concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease.\n* Cardiac ejection fraction of 50% or less.\n* Severe pulmonary dysfunction (CTC grade 3-4).\n* Severe concomitant neurological or psychiatric disease.\n* History of alcohol abuse.\n* HIV positivity.\n* Pregnancy.\n* Man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy.\n* Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.'}, 'identificationModule': {'nctId': 'NCT00909168', 'acronym': 'MYFLAI07', 'briefTitle': 'Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Udine, Italy'}, 'officialTitle': 'Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': 'MYFLAI07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efficacy of FLAIMy', 'interventionNames': ['Drug: FLAIMy - Fluda, Ida, Ara-C, Mylotarg']}], 'interventions': [{'name': 'FLAIMy - Fluda, Ida, Ara-C, Mylotarg', 'type': 'DRUG', 'description': "FLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5\n\nARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5\n\nIDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5\n\nGEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6", 'armGroupLabels': ['Efficacy of FLAIMy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33100', 'city': 'Udine', 'state': 'Italy', 'country': 'Italy', 'facility': 'University Hospital, Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'ANNA CANDONI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UUNIVERSITY HOSPITAL, UDINE, ITALY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Udine, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Hematology, SM MISERICORDIA HOSPITAL', 'investigatorFullName': 'CANDONI ANNA', 'investigatorAffiliation': 'University Hospital, Udine, Italy'}}}}