Assessing endothelial function in chronic myeloid leukemia patients on bosutinib
Condition Vasoregulation Function Endothelium in Patients With Chronic Myeloid Leukemia (CML) Getting Tyrosine Kinase Inhibitor (TKI) II Generation Bosutinib
This study is testing how a cancer treatment called bosutinib affects blood vessel function in people with chronic myeloid leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Sponsor | Samara State Medical University Academic / other |
| Drugs / interventions | imatinib, nilotinib, bosutinib |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT05682924 on ClinicalTrials.gov |
What this trial studies
This study evaluates the endothelial vasoregulatory function in patients with chronic myeloid leukemia (CML) undergoing treatment with the second-generation tyrosine kinase inhibitor bosutinib. Patients will be divided into groups based on their treatment regimen, including nilotinib and imatinib, and will undergo comprehensive examinations to assess biochemical markers of endothelial damage and vascular function. The study aims to develop an algorithm for assessing endothelial function in these patients, utilizing methods such as laser Doppler flowmetry. The findings could provide insights into the vascular health of CML patients during therapy.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 to 60 with ph-positive chronic myeloid leukemia in the chronic phase who are receiving tyrosine kinase inhibitors.
Not a fit: Patients with significant cardiovascular history or other severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of endothelial dysfunction in CML patients, enhancing their overall treatment outcomes.
How similar studies have performed: While studies on endothelial function in cancer patients exist, this specific approach focusing on bosutinib in CML is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Moscow and 1 other locations
- National Medical Research Centre for Hematology — Moscow, Russia (Recruiting)
- Samara State Medical University — Samara, Russia (Recruiting)
Study contacts
- Principal investigator: Sabina Cherenova — Samara State Medical University
- Study coordinator: Igor Davydkin
- Email: i.l.davydkin@samsmu.ru
- Phone: +78463741004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.