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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	40 Years - 60 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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 Criteria:

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05682924
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Samara State Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sabina Cherenova
Principal Investigator Affiliation	Samara State Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Myeloid Leukaemia

Additional Details

Purpose: To assess the state of endothelial vasoregulatory function in patients with chronic myelogenous leukemia receiving the II generation tyrosine kinase inhibitor bosutinib as a second line of therapy based on a comprehensive assessment of biochemical markers of endothelial damage and the results of laser Doppler flowmetry. Description of the Protocol: At the first stage, study groups will be formed. The study groups will consist of 70 patients with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, receiving nilotinib at a dose of 800 mg / day. (35 people) and bosutinib at a dose of 500 mg/day. (35 people) matched by sex and age. The control group will consist of 35 patients matched by gender and age with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, receiving imatinib at a dose of 600 mg/day. (35 people). At the second stage, it is planned to conduct a comprehensive examination of patients, including a clinical examination, a study of biochemical markers of endothelial damage and the functional state of the vascular wall. At the third stage, the relationship between the results of laboratory methods for assessing endothelial function and dynamic parameters of microcirculation, determined by laser Doppler flowmetry in patients with ph-positive chronic myeloid leukemia in the chronic phase, receiving therapy with the II generation tyrosine kinase inhibitor bosutinib, will be analyzed. At the fourth stage, it is planned to develop an algorithm for assessing the state of endothelial function in patients with ph-positive chronic myelogenous leukemia in the chronic phase using the second generation tyrosine kinase inhibitor bosutinib. Scientific novelty. 1. For the first time, an assessment of the state of endothelial function will be given on the basis of a comprehensive study using the Doppler flowmetry method and the determination of biochemical indicators of endothelial damage in patients with ph-positive chronic myeloid leukemia in the chronic phase while taking the II generation tyrosine kinase inhibitor bosutinib. 2. For the first time, an algorithm will be proposed for diagnosing the state of endothelial function in patients with ph-positive chronic myeloid leukemia in the chronic phase when using therapy with the II generation tyrosine kinase inhibitor bosutinib, based on the use of a multifactorial method of mathematical modeling. Practical significance Indicators will be determined that reflect the state of the vasoregulatory function of the endothelium in patients with ph-positive chronic myeloid leukemia in the chronic phase when using therapy with II generation tyrosine kinase inhibitors bosutinib. Taking into account the identified changes, 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. Expected results Based on a comprehensive analysis of indicators of endothelial vasoregulatory function, including biochemical parameters and an assessment of the information content of the laser Doppler flowmetry method, an algorithm for assessing the state of endothelial function in patients with ph-positive chronic myeloid leukemia in the chronic phase against the background of taking the II generation tyrosine kinase inhibitor bosutinib will be developed.

Arms & Interventions

Arms

: Study group

35 patients with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, receiving bosutinib at a dose of 500 mg / day

: Comparison group

35 patients with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, receiving nilotinib at a dose of 800 mg / day

: Control group

35 patients with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, receiving imatinib at a dose of 600 mg / day

Interventions

Diagnostic Test: - taking 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.

Contact a Trial Team

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International Sites

Moscow, Russian Federation

Status

Recruiting

Address

National Medical Research Centre for Hematology

Moscow, ,

Site Contact

Sabina Cherenova

[email protected]

+79371801521

Samara State Medical University, Samara, Russian Federation

Status

Recruiting

Address

Samara State Medical University

Samara, ,

Site Contact

Sabina Cherenova

[email protected]

+79371801521

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