Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Experimental cohort
- description
- 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
- label
- Historical (Control) Cohort
- description
- The historical or control cohort will be represented by 1848 pseudonymized adult patients (aged between \> 18 and \< 75 years) with AML treated with CHT.
Primary outcomes (2)
- measure
- Propensity Score Matching (PSM) objective
- timeFrame
- 8-12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort) Exclusion Criteria: \-
References
Publications (0)
Data not yet available