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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

Chronic Myeloid Leukaemia

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

Inclusion Criteria2

  • patients with ph-positive chronic myeloid leukemia in the chronic phase before treatment and taking tyrosine kinase inhibitors of I and II generations (imatinib, nilotinib, bosutinib);
  • availability of informed consent of the patient to participate in the study.

Exclusion Criteria12

  • history of acute cerebrovascular accident;
  • previous myocardial infarction in anamnesis;
  • the presence of diabetes mellitus type I and II;
  • the presence of chronic kidney disease C1-C5 stages;
  • the presence of coronary heart disease with its clinical manifestations (II-IV functional class);
  • the presence of hypertension III degree;
  • the presence of atherosclerotic lesions of peripheral arteries according to the color duplex sonography data of the arteries of the upper and lower extremities;
  • atrial fibrillation and flutter;
  • the presence of other oncological diseases;
  • inflammatory diseases in the acute stage;
  • the presence of mutations, in which the appointment of tyrosine kinase inhibitors of the I or II generation is not indicated (resistance to tyrosine kinase inhibitors drugs)
  • refusal of the patient from examination.

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