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

January 11, 2023 updated by: Samara State Medical University

Condition Vasoregulation Function Endothelium in Patients With Chronic Myeloid Leukemia (CML) Getting Tyrosine Kinase Inhibitor (TKI) II Generation Bosutinib

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • National Medical Research Centre for Hematology
        • Contact:
      • Samara, Russian Federation
        • Recruiting
        • Samara State Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of type of microcirculation.
Time Frame: 3 months
Type of microcirculation (normal, hyperemic, spastic, congestive) according to the LAKK-OP apparatus
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmation or exclusion of endothelial dysfunction.
Time Frame: 3 months
Biochemical marker - Human Endothelin 1 (ET-1), fmol/ml
3 months
Confirmation or exclusion of endothelial dysfunction.
Time Frame: 3 months
Biochemical marker - Homocysteine, µmol/l
3 months
Confirmation or exclusion of endothelial dysfunction.
Time Frame: 3 months
Biochemical marker - VEGF (vascular endothelial growth factor), pg/ml
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samara State Medical University

Investigators

  • Principal Investigator: Sabina Cherenova, Samara State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 15, 2023

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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