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

NCT06295029 | Not Yet Recruiting DMC

• 1 other identifier: CPA-Z05-ZC-2023-002
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Venetoclax; Machine Learning; genomics; Dose Prediction; Personalized medicine

Outcome Measures

Primary Outcomes (4)

• Overall survival (OS)

  the time from the start of the trial until the patient died from all causes

  From date of randomization until the date of first documented date of death from anyh cause, whichever came first, assessed up to 100 months

• Progression-free survival (PFS)

  From the time of trial initiation to the time of objective tumor progression or death.

  From date of randomization until the date of first documented progression, whichever came first, assessed up to 100 months

• Overall adverse event rate

  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

  up to 24 weeks

• Incidence of grade III and above adverse events

  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

  up to 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Biospecimen

Retention: SAMPLES WITH DNA

Two ml of peripheral blood samples from patients were placed in Ethylenediaminetetraacetic acid(EDTA) tubes,DeoxyriboNucleic Acid(DNA) was extracted and cryopreserved for use in the determination of relevant SNPs

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Yudong Qiu

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Central Study Contacts

Mengying Liu

CONTACT

025-83106666; liumengying@njglyy.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2024

Record last verified: 2024-03