NCT05682924Completed
Condition Vasoregulation Function Endothelium in Patients With CML Getting TKI II Generation Bosutinib
Condition Vasoregulation Function Endothelium in Patients With Chronic Myeloid Leukemia (CML) Getting Tyrosine Kinase Inhibitor (TKI) II Generation Bosutinib
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 105 (actual)
- First submitted
- 14 Dec 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Samara State Medical University
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT05682924
What you commit to
- Study type: Observational
- Participants enrolled: 105
- From 1 Oct 2022 to the primary completion date, 1 Sept 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous myocardial infarction in anamnesis;
- 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)
Other illness
- history of acute cerebrovascular accident;
- 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 other oncological diseases;
- inflammatory diseases in the acute stage;
Other
- 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;
- refusal of the patient from examination.
Who the study is looking for
- 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.
Age in the registry: 40 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Research Centre for Hematology Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Samara State Medical University Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.