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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-60
SponsorSamara State Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

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 test

    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.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Study group1 intervention
Group B: Comparison group1 intervention
Group C: Control group1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of type of microcirculation.

Type of microcirculation (normal, hyperemic, spastic, congestive) according to the LAKK-OP apparatus

Time frame
3 months

Secondary outcomes

1

Confirmation or exclusion of endothelial dysfunction.

Biochemical marker - Human Endothelin 1 (ET-1), fmol/ml

Time frame
during inclusion
2

Confirmation or exclusion of endothelial dysfunction.

Biochemical marker - VEGF (vascular endothelial growth factor), pg/ml

Time frame
3 months
3

Confirmation or exclusion of endothelial dysfunction.

Biochemical marker - Homocysteine, µmol/l

Time frame
6 months

Other outcomes

Sponsors and contacts

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