RecruitingNCT07420790

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 <75years) 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


Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Enrollment

1,941 participants

Start Date

Feb 20, 2026

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort)

Exclusion Criteria1

  • \-

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

USD TMO Adulti

Brescia, Italy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07420790


Related Trials