About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Patients with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, who meet the inclusion/exclusion criteria, receiving therapy with the tyrosine kinase inhibitors II generation bosutinib, nilotinib, and the tyrosine kinase inhibitors I generation imatinib.
Trial design
Cohort
Prospective
Treatments tested in this trial
taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry
Diagnostic testIn 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.
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of type of microcirculation.
Type of microcirculation (normal, hyperemic, spastic, congestive) according to the LAKK-OP apparatus
Secondary outcomes
Confirmation or exclusion of endothelial dysfunction.
Biochemical marker - Human Endothelin 1 (ET-1), fmol/ml
Confirmation or exclusion of endothelial dysfunction.
Biochemical marker - VEGF (vascular endothelial growth factor), pg/ml
Confirmation or exclusion of endothelial dysfunction.
Biochemical marker - Homocysteine, µmol/l
Sponsors and contacts
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