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Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics - Trial NCT06295029

Access comprehensive clinical trial information for NCT06295029 through Pure Global AI's free database. This phase not specified trial is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School and is currently Not yet recruiting. The study focuses on Acute Myeloid Leukemia. Target enrollment is 200 participants.

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NCT06295029
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Trial Details
ClinicalTrials.gov โ€ข NCT06295029
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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

Study Focus

Acute Myeloid Leukemia

Observational

Sponsor & Location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Timeline & Enrollment

N/A

Mar 01, 2024

Dec 31, 2027

200 participants

Primary Outcome

Overall survival (OS),Progression-free survival (PFS),Overall adverse event rate,Incidence of grade III and above adverse events

Summary

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.

ICD-10 Classifications

Myeloid leukaemia
Acute myeloblastic leukaemia [AML]
Myeloid leukaemia, unspecified
Acute myelomonocytic leukaemia
Acute myeloid leukaemia with 11q23-abnormality

Data Source

ClinicalTrials.gov

NCT06295029

Non-Device Trial