Comparing venetoclax plus decitabine to intensive chemotherapy for older AML patients eligible for stem-cell transplant using AI-matched controls.
Official title: 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
Run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · NCT07420790 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 1941 (estimated) |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brescia, Italy) |
| Status | Recruiting |
| Started | February 20, 2026 |
| Main results expected | July 2026 |
| Study ends | December 2026 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07420790 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort) Exclusion Criteria: \-
Where it's running
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USD TMO Adulti
Brescia, Italy, Italy Recruiting
Study contacts
- Study coordinator: Domenico Russo, MD
- Email: domenico.russo@unibs.it
- Phone: 00390303996811
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.