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 (VenDec-AI)
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
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
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Domenico Russo, MD
- Phone Number: 00390303996811
- Email: domenico.russo@unibs.it
Study Locations
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Italy
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Brescia, Italy, Italy, 25100
- Recruiting
- USD TMO Adulti
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Experimental Cohort The experimental cohort will be represented by 93 elderly patients (aged ≥60 and <75 years) with AML deemed to be eligible for Allo-HSCT who were treated with VENDEC regimen and submitted to Allo-HSCT in first CR.
Historical (Control) Cohort The historical or control cohort will be represented by 1848 pseudonymized adult patients (aged between > 18 and < 75 years) with AML treated with CHT
Description
Inclusion Criteria:
- Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort)
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Experimental cohort
The experimental cohort will be represented by 93 elderly patients (aged ≥60 and <75 years) with AML deemed to be eligible for Allo-HSCT who were treated with VENDEC regimen and submitted to Allo-HSCT in first CR
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Historical (Control) Cohort
The historical or control cohort will be represented by 1848 pseudonymized adult patients (aged between > 18 and < 75 years) with AML treated with CHT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Propensity Score Matching (PSM) objective
Time Frame: 8-12 months
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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, <75 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. Propensity 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/high risk AML patients older than 60 years and offering them a higher probability to be transplanted and cured. |
8-12 months
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Artificial Intelligence objectives
Time Frame: 8-12 months
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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, <75 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. AI 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. |
8-12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP 6575
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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