[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625296":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":20,"armGroups":21,"interventions":16,"overallOfficials":16,"centralContacts":28,"locations":34,"responsibleParty":48,"collaborators":16,"id":52,"slug":16,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":16,"studyType":65,"phases":16,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":37,"whyStopped":16,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Propensity Score Matching (PSM) objective","Design of a model based on Generative Artificial Intelligence and the Propensity Score Matching methodology for the validation of the \"Phase II Study on Venetoclax (VEN) plus Decitabine (DEC) (VEN-DEC) in elderly patients (≥60, \\\u003C75 years) with newly diagnosed acute myeloid leukemia (AML) eligible for allogeneic stem cell transplantation (Allo-SCT)\". Evaluation of an exploratory approach as an alternative to a randomized phase III study.\n\nPropensity Score Matching objective The PSM method can be used to reduce the effects of confounding when using observational data to estimate treatment effects. The objective of this analysis is to validate the VEN-DEC treatment Program as more effective than the conventional chemotherapy treatment for inducing CR in intermediate\u002Fhigh risk AML patients older than 60 years and offering them a higher probability to be transplanted and cured.","8-12 months",{"measure":14,"description":15,"timeFrame":12},"Artificial Intelligence objectives","Design of a model based on Generative Artificial Intelligence and the Propensity Score Matching methodology for the validation of the \"Phase II Study on Venetoclax (VEN) plus Decitabine (DEC) (VEN-DEC) in elderly patients (≥60, \\\u003C75 years) with newly diagnosed acute myeloid leukemia (AML) eligible for allogeneic stem cell transplantation (Allo-SCT)\". Evaluation of an exploratory approach as an alternative to a randomized phase III study.\n\nAI Objectives By AI generative methodology, the objective is confirming the superiority of VENDEC in AML patients older than 60 years and acquiring information useful to guide the use of VEN-DEC or similar treatments in AML patients with clinical features similar to those of the VEN-DEC phase II study patients' population but younger than 60 years.",null,{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":18,"timePerspective":19,"maskingInfo":16},"COHORT","RETROSPECTIVE","Experimental Cohort The experimental cohort will be represented by 93 elderly patients (aged ≥60 and \\\u003C75 years) with AML deemed to be eligible for Allo-HSCT who were treated with VENDEC regimen and submitted to Allo-HSCT in first CR.\n\nHistorical (Control) Cohort The historical or control cohort will be represented by 1848 pseudonymized adult patients (aged between \\> 18 and \\\u003C 75 years) with AML treated with CHT",[22,25],{"label":23,"type":16,"description":24,"interventionNames":16},"Experimental cohort","The experimental cohort will be represented by 93 elderly patients (aged ≥60 and \\\u003C75 years) with AML deemed to be eligible for Allo-HSCT who were treated with VENDEC regimen and submitted to Allo-HSCT in first CR",{"label":26,"type":16,"description":27,"interventionNames":16},"Historical (Control) Cohort","The historical or control cohort will be represented by 1848 pseudonymized adult patients (aged between \\> 18 and \\\u003C 75 years) with AML treated with CHT.",[29],{"name":30,"role":31,"phone":32,"phoneExt":16,"email":33},"Domenico Russo, MD","CONTACT","00390303996811","domenico.russo@unibs.it",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":39,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":16},"USD TMO Adulti","RECRUITING","Brescia","Italy","25100","IT",{"type":43,"coordinates":44},"Point",[45,46],10.21472,45.53558,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Prof Domenico Russo","Ordinary Professor, MD, PhD, Principal Investigator","100625296",false,"NCT07420790","Design and Validation of a Generative AI and Propensity Score Matching Model for the VEN-DEC Phase II Study in Elderly AML Eligible for Allo-SCT; Evaluation of an Exploratory Approach Respect to a Randomized Phase III Trial","Designing a Generative AI Model and Propensity Score Matching Methodology for Validation of \"The Phase II Study on Venetoclax (VEN) Plus Decitabine (DEC) (VEN-DEC) in Elderly (e60 \u003C75years) Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Eligible for Allogeneic Stem Cell Transplantation (Allo-SCT)\". Evaluation of an Exploratory Approach Respect to a Randomized Phase III Trial","VenDec-AI","Inclusion Criteria:\n\n* Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort)\n\nExclusion Criteria:\n\n\\-","ALL","18 Years","75 Years",{"count":63,"type":64},1941,"ESTIMATED","OBSERVATIONAL","To better delineate the contribution of VEN-DEC to the treatment of AML patients aged between ≥ 60 and \\\u003C 75 years and deemed fit for Allo-HSCT, real-world data on a patient-level basis will be collected and utilized to generate a matched control cohort of same AML patients treated with intensive chemotherapy.\n\nIn addittion, to further validate the efficacy of the VEN-DEC treatment approach in elderly AML patients, an advanced generative AI model will be constructed and trained using the historical cohort data. The AI model aims to simulate outcomes based on the standard",[68],"Acute Myeloid Leukemia",[70,71,72,73],"Acute Myeloid Leukaemia","Artificial Intelligence","Chemotherapy","Chemo-free regimen","2026-04-27",{"date":76,"type":77},"2026-04-30","ACTUAL",{"date":79,"type":77},"2026-02-20",{"date":81,"type":64},"2026-12",{"name":5,"class":6},1]