Acute Myeloid LeukemiaVenDec-AINCT07420790
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
An observational study of Acute Myeloid Leukemia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 1,941 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukaemia, Artificial Intelligence, Chemotherapy, Chemo-free regimen
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start20 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,941 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Domenico Russo, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420790
- Sponsor's protocol ID
- NP 6575
- Acronym
- VenDec-AI
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07420790
- Acronym / sponsor ID
- VenDec-AI / NP 6575
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukaemia, Artificial Intelligence, Chemotherapy, Chemo-free regimen
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,941 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Propensity Score Matching (PSM) objective
Time frame: 8-12 months
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.
Artificial Intelligence objectives
Time frame: 8-12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domenico Russo, MD (00390303996811, domenico.russo@unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propensity Score Matching (PSM) objective (time frame: 8-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.