Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics
Severe neutropenia caused by venetoclax,a B-cell lymphoma-2(BCL-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 leukemia(AML) 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 polymorphism(SNP) information and the adverse reactions of the AML patients, and the model was constructed through machine learning.
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years old, regardless of gender; Diagnosed as an AML patient according to the Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (Non Acute Promyelocytic Leukemia) in China (2021 Edition) and receiving treatment with venetoclax; Before receiving venetoclax treatment, absolute neutrophil count (ANC) ≥ 1.0 ×10 ^9/L, white blood cell count (WBC) ≥ 2.0 ×10 ^9/L, platelet count (PLT) ≥ 50 ×10 ^9/L, and hemoglobin (HB) ≥ 90g /L; Before receiving venetoclax treatment, liver and kidney function were normal (aspartate aminotransferase ≤ 3 times the upper limit of normal (ULN), alanine aminotransferase ≤ 3.0 x ULN, bilirubin ≤ 1.5 x ULN, urea nitrogen:3.2-7.1 mmol/L, glomerular filtration rate (eGFR) ≥ 60ml/min; Sign an informed consent form.  Exclusion Criteria:  Age<18 years old; Non AML patients; Patients who plan to use a treatment regimen without venetoclax; Patients with poor medication adherence; Liver and kidney function damage before medication; Before medication, ANC<1.0 x 10 ^9/L or WBC<2.0 x 10 ^9/L or PLT<50 x 10 ^9/L or HB<90g /L; Pregnant and lactating women; Cases deemed unsuitable for inclusion by researchers - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study aims to include 200 patients with AML who were treated with venetoclax. A database of venetoclax medication for AML patients will be constructed based on demographic information, medication information, laboratory test information, blood drug concentration, SNPs, and drug-related adverse reactions. Randomly divide the data into training and testing sets in a 7:3 ratio, and construct the model through machine learning. - SamplingMethod: Non-Probability Sample