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

NCT05682924 | Recruiting DMC

• 1 other identifier: 20221112
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Myeloid Leukaemia

Keywords

chronic myeloid leukaemia; tyrosine kinase inhibitor; endothelium; endothelial dysfunction; bosutinib

Outcome Measures

Primary Outcomes (1)

• Evaluation of type of microcirculation.

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

  3 months

Secondary Outcomes (3)

• Confirmation or exclusion of endothelial dysfunction.

  during inclusion

• Confirmation or exclusion of endothelial dysfunction.

  3 months

• Confirmation or exclusion of endothelial dysfunction.

  6 months

Study Arms (3)

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

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

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

Interventions

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.

Comparison group; Control group; Study group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samara State Medical University: lead

Study Sites (2)

National Medical Research Centre for Hematology

Moscow, Russia

RECRUITING

Samara State Medical University

Samara, Russia

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabina Cherenova

  Samara State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Davydkin

CONTACT

+78463741004; i.l.davydkin@samsmu.ru

Sabina Cherenova

CONTACT

+79371801521; s.g.cherenova@samsmu.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 12, 2023
• Study Start: October 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 15, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

RU (2)