Comparing venetoclax plus decitabine to intensive chemotherapy for older AML patients eligible for stem-cell transplant using AI-matched controls.
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
This project will try to see if venetoclax plus decitabine (VEN‑DEC) works as well as standard intensive chemotherapy for people aged 60–74 with AML who are fit for allogeneic stem-cell transplant by using real-world data and AI to create matched comparison groups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1941 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brescia, Italy) |
| Trial ID | NCT07420790 on ClinicalTrials.gov |
What this trial studies
Researchers will collect patient-level real-world data from elderly AML patients treated either with VEN‑DEC or standard intensive chemotherapy, focusing on those aged 60–74 who are considered fit for allogeneic HSCT. They will use propensity score matching to build a closely matched control cohort from historical patients treated with intensive chemotherapy. In parallel, a generative AI model will be trained on the historical cohort to simulate expected outcomes and validated against the matched controls. The aim is to see whether this observational, AI-supported approach can approximate conclusions a randomized Phase III trial might produce.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 to 74 with acute myeloid leukemia who are deemed fit for allogeneic hematopoietic stem-cell transplantation and who received VEN‑DEC or intensive chemotherapy.
Not a fit: Patients outside the 60–74 age range, those not considered transplant-eligible, or those treated with other regimens are unlikely to have results that directly apply to their care.
Why it matters
Potential benefit: If successful, the approach could clarify whether VEN‑DEC is an effective, less toxic alternative to intensive chemotherapy for older patients eligible for transplant, helping clinicians and patients choose treatments when randomized data are limited.
How similar studies have performed: Previous trials have shown activity of venetoclax combined with hypomethylating agents in older AML patients, but using generative AI plus propensity matching to emulate randomized comparisons in transplant-eligible patients is a novel and not yet widely validated approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort) Exclusion Criteria: \-
Where this trial is running
Brescia, Italy
- USD TMO Adulti — Brescia, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Domenico Russo, MD
- Email: domenico.russo@unibs.it
- Phone: 00390303996811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.