Clinical trial · Observational

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

NCT06295029CI-TRIAL-00074707not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Acute Myeloid Leukemia	Acute Myeloid Leukemia	CURATED_BROADER	0.80

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (4)

measure
Overall survival (OS)
timeFrame
From date of randomization until the date of first documented date of death from anyh cause, whichever came first, assessed up to 100 months
description
the time from the start of the trial until the patient died from all causes
measure
Progression-free survival (PFS)
timeFrame
From date of randomization until the date of first documented progression, whichever came first, assessed up to 100 months
description
From the time of trial initiation to the time of objective tumor progression or death.
measure
Overall adverse event rate
timeFrame
up to 24 weeks
description
According to the association evaluation of adverse drug reactions adopted by the National Adverse Drug Reaction Monitoring Center, the adverse drug reactions occurred in this study were classified into five levels: sure, probable, probable, suspicious and impossible.Adverse reactions with reference to the U.S. department of health and human services release of the common adverse reaction term evaluation criteria (CommonTerminologyCriteriaforAdverseEvents CTCAE) version 5.0

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age ≥ 18 years old, regardless of gender;
2. 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;
3. 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;
4. 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;
5. Sign an informed consent form.

Exclusion Criteria:

1. Age\<18 years old;
2. Non AML patients;
3. Patients who plan to use a treatment regimen without venetoclax;
4. Patients with poor medication adherence;
5. Liver and kidney function damage before medication;
6. 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;
7. Pregnant and lactating women;
8. Cases deemed unsuitable for inclusion by researchers

References

Publications (0)

Data not yet available

No reference posted for this study.