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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
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2026 to Feb 20, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07420790
Lead Sponsor Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 1,941 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov