RecruitingNCT05682924

Condition Vasoregulation Function Endothelium in Patients With CML Getting TKI II Generation Bosutinib

Condition Vasoregulation Function Endothelium in Patients With Chronic Myeloid Leukemia (CML) Getting Tyrosine Kinase Inhibitor (TKI) II Generation Bosutinib


Sponsor

Samara State Medical University

Enrollment

105 participants

Start Date

Oct 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The study will study the state of the endothelium in patients with chronic myeloid leukemia during therapy with the II generation tyrosine kinase inhibitor bosutinib. Patients will be divided into groups receiving nilotinib 800mg/day, bosutinib 500mg/day, and imatinib 600mg/day. A comprehensive examination of patients will be carried out, including a clinical examination, a study of biochemical markers of endothelial damage and the functional state of the vascular wall. An algorithm will be developed for assessing the state of endothelial function in patients with ph-positive chronic myeloid leukemia in the chronic phase when using the second-generation tyrosine kinase inhibitor bosutinib.


Eligibility

Min Age: 40 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is measuring blood vessel function in patients with chronic myeloid leukemia (CML) — a blood cancer — who are being treated with targeted drugs called tyrosine kinase inhibitors (TKIs), specifically including a second-generation drug called bosutinib. Researchers want to understand how these medications affect the health of blood vessel walls over time. **You may be eligible if...** - You have been diagnosed with Philadelphia chromosome-positive CML in the chronic phase - You are currently taking a first- or second-generation TKI (imatinib, nilotinib, or bosutinib) - You have provided informed consent **You may NOT be eligible if...** - You have had a stroke or heart attack in the past - You have diabetes (type 1 or 2), chronic kidney disease, significant coronary artery disease, or severe high blood pressure - You have an irregular heartbeat (atrial fibrillation) or peripheral artery disease - You have another active cancer - Your cancer has developed resistance to TKI drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTtaking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry

In the study, blood will be taken from patients with chronic myelogenous leukemia in the chronic phase to determine biochemical parameters (endothelin-1, homocysteine, VEGF (vascular endothelial growth factor)), as well as a study of microcirculation in these groups of patients using the method of laser Doppler flowmetry, to study the function of the endothelium.


Locations(2)

National Medical Research Centre for Hematology

Moscow, Russia

Samara State Medical University

Samara, Russia

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NCT05682924


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