NCT06295029Not yet recruiting
Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics
Dose Optimization and Personalized Medication Software Research of BCL-2 Inhibitor Based on Machine Learning Combined With Genomics in Patients With Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 6 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 26 Feb 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06295029
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Mar 2024 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with poor medication adherence;
- Liver and kidney function damage before medication;
Lab values
- 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;
Age
- Age\<18 years old;
Other
- Non AML patients;
- Patients who plan to use a treatment regimen without venetoclax;
- Pregnant and lactating women;
- Cases deemed unsuitable for inclusion by researchers
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.