Chronic Myeloid LeukaemiaNCT05682924
Condition Vasoregulation Function Endothelium in Patients With CML Getting TKI II Generation Bosutinib
An observational study of Chronic Myeloid Leukaemia, run by Samara State Medical University at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Myeloid Leukaemia
- What is being tested?
- taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry
- How many people
- 105 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Oct 2022to 15 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, who meet the inclusion/exclusion criteria, receiving therapy with the tyrosine kinase inhibitors II generation bosutinib, nilotinib, and the tyrosine kinase inhibitors I generation imatinib.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
National Medical Research Centre for Hematology
Moscow
Samara State Medical University
Samara
About this study
Official title: Condition Vasoregulation Function Endothelium in Patients With Chronic Myeloid Leukemia (CML) Getting Tyrosine Kinase Inhibitor (TKI) II Generation Bosutinib
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.
Read the detailed description
Purpose: To assess the state of endothelial vasoregulatory function in patients with chronic myelogenous leukemia receiving the II generation tyrosine kinase inhibitor bosutinib as a second line of therapy based on a comprehensive assessment of biochemical markers of endothelial damage and the results of laser Doppler flowmetry.
Description of the Protocol: At the first stage, study groups will be formed. The study groups will consist of 70 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. (35 people) and bosutinib at a dose of 500 mg/day. (35 people) matched by sex and age. The control group will consist of 35 patients matched by gender and age with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, receiving imatinib at a dose of 600 mg/day. (35 people).
At the second stage, it is planned to conduct a comprehensive examination of patients, including a clinical examination, a study of biochemical markers of endothelial damage and the functional state of the vascular wall.
At the third stage, the relationship between the results of laboratory methods for assessing endothelial function and dynamic parameters of microcirculation, determined by laser Doppler flowmetry in patients with ph-positive chronic myeloid leukemia in the chronic phase, receiving therapy with the II generation tyrosine kinase inhibitor bosutinib, will be analyzed.
At the fourth stage, it is planned to develop an algorithm for assessing the state of endothelial function in patients with ph-positive chronic myelogenous leukemia in the chronic phase using the second generation tyrosine kinase inhibitor bosutinib.
Scientific novelty
- For the first time, an assessment of the state of endothelial function will be given on the basis of a comprehensive study using the Doppler flowmetry method and the determination of biochemical indicators of endothelial damage in patients with ph-positive chronic myeloid leukemia in the chronic phase while taking the II generation tyrosine kinase inhibitor bosutinib.
- For the first time, an algorithm will be proposed for diagnosing the state of endothelial function in patients with ph-positive chronic myeloid leukemia in the chronic phase when using therapy with the II generation tyrosine kinase inhibitor bosutinib, based on the use of a multifactorial method of mathematical modeling.
Practical significance Indicators will be determined that reflect the state of the vasoregulatory function of the endothelium in patients with ph-positive chronic myeloid leukemia in the chronic phase when using therapy with II generation tyrosine kinase inhibitors bosutinib.
Taking into account the identified changes, 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.
Expected results Based on a comprehensive analysis of indicators of endothelial vasoregulatory function, including biochemical parameters and an assessment of the information content of the laser Doppler flowmetry method, an algorithm for assessing the state of endothelial function in patients with ph-positive chronic myeloid leukemia in the chronic phase against the background of taking the II generation tyrosine kinase inhibitor bosutinib will be developed.
- Conditions
- Chronic Myeloid Leukaemia
- Being tested
- taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry
- Keywords
- chronic myeloid leukaemia, tyrosine kinase inhibitor, endothelium, endothelial dysfunction, bosutinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetryDiagnostic test
In the study, blood will be taken from patients with chronic myelogenous leukemia in the chronic phase to determine biochemical parameters (endothelin-1, homocysteine, VEGF (vascular endothelial growth factor)), as well as a study of microcirculation in these groups of patients using the method of laser Doppler flowmetry, to study the function of the endothelium.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry | |
| 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 Receives: Diagnostic Test: taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry | |
| 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 Receives: Diagnostic Test: taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of type of microcirculation.
Type of microcirculation (normal, hyperemic, spastic, congestive) according to the LAKK-OP apparatus
Measured: 3 months
Secondary outcomes (3)
Confirmation or exclusion of endothelial dysfunction.
Biochemical marker - Human Endothelin 1 (ET-1), fmol/ml
Measured: during inclusion
Confirmation or exclusion of endothelial dysfunction.
Biochemical marker - VEGF (vascular endothelial growth factor), pg/ml
Measured: 3 months
Confirmation or exclusion of endothelial dysfunction.
Biochemical marker - Homocysteine, µmol/l
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Oct 2022
- Primary completion1 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabina Cherenova, Principal investigator, Samara State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682924
- Sponsor's protocol ID
- 20221112
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Condition Vasoregulation Function Endothelium in Patients With Chronic Myeloid Leukemia (CML) Getting Tyrosine Kinase Inhibitor (TKI) II Generation Bosutinib
- ClinicalTrials.gov ID
- NCT05682924
- Acronym / sponsor ID
- 20221112
- Conditions
- Chronic Myeloid Leukaemia
- Keywords
- chronic myeloid leukaemia, tyrosine kinase inhibitor, endothelium, endothelial dysfunction, bosutinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose: To assess the state of endothelial vasoregulatory function in patients with chronic myelogenous leukemia receiving the II generation tyrosine kinase inhibitor bosutinib as a second line of therapy based on a comprehensive assessment of biochemical markers of endothelial damage and the results of laser Doppler flowmetry.
Description of the Protocol: At the first stage, study groups will be formed. The study groups will consist of 70 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. (35 people) and bosutinib at a dose of 500 mg/day. (35 people) matched by sex and age. The control group will consist of 35 patients matched by gender and age with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, receiving imatinib at a dose of 600 mg/day. (35 people).
At the second stage, it is planned to conduct a comprehensive examination of patients, including a clinical examination, a study of biochemical markers of endothelial damage and the functional state of the vascular wall.
At the third stage, the relationship between the results of laboratory methods for assessing endothelial function and dynamic parameters of microcirculation, determined by laser Doppler flowmetry in patients with ph-positive chronic myeloid leukemia in the chronic phase, receiving therapy with the II generation tyrosine kinase inhibitor bosutinib, will be analyzed.
At the fourth stage, it is planned to develop an algorithm for assessing the state of endothelial function in patients with ph-positive chronic myelogenous leukemia in the chronic phase using the second generation tyrosine kinase inhibitor bosutinib.
Scientific novelty
- For the first time, an assessment of the state of endothelial function will be given on the basis of a comprehensive study using the Doppler flowmetry method and the determination of biochemical indicators of endothelial damage in patients with ph-positive chronic myeloid leukemia in the chronic phase while taking the II generation tyrosine kinase inhibitor bosutinib.
- For the first time, an algorithm will be proposed for diagnosing the state of endothelial function in patients with ph-positive chronic myeloid leukemia in the chronic phase when using therapy with the II generation tyrosine kinase inhibitor bosutinib, based on the use of a multifactorial method of mathematical modeling.
Practical significance Indicators will be determined that reflect the state of the vasoregulatory function of the endothelium in patients with ph-positive chronic myeloid leukemia in the chronic phase when using therapy with II generation tyrosine kinase inhibitors bosutinib.
Taking into account the identified changes, 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.
Expected results Based on a comprehensive analysis of indicators of endothelial vasoregulatory function, including biochemical parameters and an assessment of the information content of the laser Doppler flowmetry method, an algorithm for assessing the state of endothelial function in patients with ph-positive chronic myeloid leukemia in the chronic phase against the background of taking the II generation tyrosine kinase inhibitor bosutinib will be developed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry35 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 | – | Diagnostic Test: taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry35 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 | – | Diagnostic Test: taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetry35 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with ph-positive chronic myeloid leukemia in the chronic phase, aged 40 to 60 years, who meet the inclusion/exclusion criteria, receiving therapy with the tyrosine kinase inhibitors II generation bosutinib, nilotinib, and the tyrosine kinase inhibitors I generation imatinib.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taking blood for the study of biochemical parameters and the study of microcirculation using the method of laser Doppler flowmetryIn the study, blood will be taken from patients with chronic myelogenous leukemia in the chronic phase to determine biochemical parameters (endothelin-1, homocysteine, VEGF (vascular endothelial growth factor)), as well as a study of microcirculation in these groups of patients using the method of laser Doppler flowmetry, to study the function of the endothelium. | Diagnostic test | Comparison group, Control group, Study group |
Primary outcome
Evaluation of type of microcirculation.
Time frame: 3 months
Type of microcirculation (normal, hyperemic, spastic, congestive) according to the LAKK-OP apparatus
3 secondary outcomes
Confirmation or exclusion of endothelial dysfunction.
Time frame: during inclusion
Confirmation or exclusion of endothelial dysfunction.
Time frame: 3 months
Confirmation or exclusion of endothelial dysfunction.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina Cherenova principal investigator
Samara State Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukaemia, run by Samara State Medical University at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of type of microcirculation. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.