Clinical Trial

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

Study acronym: VenDec-AI
Recruiting
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Record status
This record was last updated April 30, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
To better delineate the contribution of VEN-DEC to the treatment of AML patients aged between ≥ 60 and \< 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. In 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
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-01
Trial Details
NCT Number NCT07420790
Lead Sponsor Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions Acute Myeloid Leukemia
Enrollment 1,941 participants
Start Date 2026-02-20
Primary Completion 2026-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-30