Chronic Myelogenous Leukemia (CML) Clinical Trials

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Condition Vasoregulation Function Endothelium in Patients With Chronic Myeloid Leukemia (CML) Getting Tyrosine Kinase Inhibitor (TKI) II Generation Bosutinib

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
National Medical Research Centre for Hematology
RECRUITING
Moscow
Samara State Medical University
RECRUITING
Samara
Contact Information
Primary
Igor Davydkin
i.l.davydkin@samsmu.ru
+78463741004
Backup
Sabina Cherenova
s.g.cherenova@samsmu.ru
+79371801521
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2025-09-15
Participants
Target number of participants: 105
Treatments
Study group
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
Comparison group
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
Control group
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
Sponsors
Leads: Samara State Medical University

This content was sourced from clinicaltrials.gov