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Trial Title:
Condition Vasoregulation Function Endothelium in Patients With CML Getting TKI II Generation Bosutinib
NCT ID:
NCT05682924
Condition:
Chronic Myeloid Leukaemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Conditions: Keywords:
chronic myeloid leukaemia
tyrosine kinase inhibitor
endothelium
endothelial dysfunction
bosutinib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry
Description:
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.
Arm group label:
Comparison group
Arm group label:
Control group
Arm group label:
Study group
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
40 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Medical Research Centre for Hematology
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Sabina Cherenova
Phone:
+79371801521
Email:
s.g.cherenova@samsmu.ru
Facility:
Name:
Samara State Medical University
Address:
City:
Samara
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Sabina Cherenova
Phone:
+79371801521
Email:
s.g.cherenova@samsmu.ru
Start date:
October 1, 2022
Completion date:
May 15, 2023
Lead sponsor:
Agency:
Samara State Medical University
Agency class:
Other
Source:
Samara State Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05682924
