Condition Vasoregulation Function Endothelium in Patients With CML Getting TKI II Generati
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
| Condition(s) | Chronic Myeloid Leukaemia |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 ext |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Lead sponsor | Samara State Medical University |
| Locations | Moscow, Russia; Samara, Russia |
| Start date | 2022-10-01 |
| NCT ID | NCT05682924 |
| Official listing | https://clinicaltrials.gov/study/NCT05682924 |