An observational study in Acute Myeloid Leukemia, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Observational
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
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 1,941 is above the median of 114 across 395 observational studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
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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.
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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Exclusion Criteria:
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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
The historical or control cohort will be represented by 1848 pseudonymized adult patients (aged between \> 18 and \< 75 years) with AML treated with CHT.
Propensity Score Matching (PSM) objective
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.
Time frame: 8-12 months
Artificial Intelligence objectives
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.
Time frame: 8-12 months
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia