Actively Recruiting

Age: 40Years - 60Years
All Genders
NCT05682924

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

Led by Samara State Medical University · Updated on 2024-12-16

105

Participants Needed

2

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase before treatment and receiving tyrosine kinase inhibitors of first or second generation (imatinib, nilotinib, bosutinib)
  • Patient provides informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • History of acute cerebrovascular accident
  • Previous myocardial infarction
  • Presence of type I or II diabetes mellitus
  • Chronic kidney disease stages C1 to C5
  • Coronary heart disease with clinical symptoms (functional class II-IV)
  • Hypertension grade III
  • Atherosclerotic lesions of peripheral arteries detected by color duplex sonography
  • Atrial fibrillation or flutter
  • Presence of other cancers
  • Active inflammatory diseases
  • Mutations causing resistance to first or second generation tyrosine kinase inhibitors
  • Patient refuses examination

AI-Screening

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Trial Site Locations

Total: 2 locations

1

National Medical Research Centre for Hematology

Moscow, Russia

Actively Recruiting

2

Samara State Medical University

Samara, Russia

Actively Recruiting

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Research Team

I

Igor Davydkin

CONTACT

S

Sabina Cherenova

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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