Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukaemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Study group
- description
- 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
- interventionNames
- Diagnostic Test: taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry
- label
- Comparison group
- description
- 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
- interventionNames
- Diagnostic Test: taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry
- label
- Control group
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
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