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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,941
- 主要终点
- Propensity Score Matching (PSM) objective
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort)
排除标准
- 未提供
研究组 & 干预措施
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.
结局指标
主要结局
Propensity Score Matching (PSM) objective
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Prof Domenico Russo
Ordinary Professor, MD, PhD, Principal Investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia