Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295029
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-26
Brief Title:
Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
Dose Optimization and Personalized Medication Software Research of BCL-2 Inhibitor Based on Machine Learning Combined With Genomics in Patients With Acute Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe neutropenia caused by venetoclaxa B-cell lymphoma-2BCL-2 inhibitor is the main cause of venetoclax tapering drug discontinuation and treatment delay This study combines machine learning and genomics hoping to develop models to predict venetoclax dose in Acute myeloid leukemiaAML patients and compare the efficacy and safety differences of model-guided individualized medication regimen with current conventional regimen According to the demographic information the drug information the drug concentration of the target patients the laboratory examination the single nucleotide polymorphismSNP information and the adverse reactions of the AML patients and the model was constructed through machine learning
Detailed Description:
IntroductionThe successful development of venetoclax offers new hope for AML patients not eligible for strong induction chemotherapy However there are some clinical problems such as severe neutropenia is the main reason for treatment delay and discontinuation of patients The Asian population has higher drug exposure than the non-Asian population and the blood concentration of venetoclax varies greatly individually and the blood drug concentration is associated with efficacy and adverse effects We urgently need an individualized study of venetoclax for Chinese AML patients to reduce the incidence of adverse events while ensuring efficacy
ObjectiveConstruction of a venetoclax dose prediction model for AML patients based on machine learning combined genomics
Methods1Venetoclax plasma concentration determinationdetermination of SNPs of related genes in patient blood cells 2venetoclax dose prediction model for AML patients based on machine learning techniques combined with genomics Collect the clinical data and establish a database Mining variables to explore the factors affecting the dosage of venetoclax Building a predictive model based on a machine-learning algorithm Model performance was evaluated and the optimal model was selected Interpretation and optimization of the model
The AML patients were conditionally screened by the study physician involved in the project department to assess their enrollment Communicate fully with the patients and their family members who meet the enrollment criteria obtain the patients informed consent and sign the informed consent form After enrollment patient clinical data were recorded Evaluation according to the efficacy and safety evaluation criteria
ObjectiveConstruction of a venetoclax dose prediction model for AML patients based on machine learning combined genomics
Methods1Venetoclax plasma concentration determinationdetermination of SNPs of related genes in patient blood cells 2venetoclax dose prediction model for AML patients based on machine learning techniques combined with genomics Collect the clinical data and establish a database Mining variables to explore the factors affecting the dosage of venetoclax Building a predictive model based on a machine-learning algorithm Model performance was evaluated and the optimal model was selected Interpretation and optimization of the model
The AML patients were conditionally screened by the study physician involved in the project department to assess their enrollment Communicate fully with the patients and their family members who meet the enrollment criteria obtain the patients informed consent and sign the informed consent form After enrollment patient clinical data were recorded Evaluation according to the efficacy and safety evaluation criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None