Condition Vasoregulation Function Endothelium in Patients With CML Getting TKI II Generation Bosutinib

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised at 2 of 2 sites
    • Study description expanded, about 2 words
  2. Primary completion date: May 1, 2023 to Sep 1, 2025
    • Study completion date: May 15, 2023 to Sep 15, 2025
    • Secondary endpoints: details revised at 3 of 3 entries
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05682924
Lead Sponsor Samara State Medical University
Conditions
(from sponsor)		 Chronic Myeloid Leukaemia
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov