Leukemic Stem Cell Detection for Chronic Myeloid Leukemia Patients With Major Molecular Response
NCT ID: NCT04104035
Last Updated: 2019-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-08-13
2021-01-31
Brief Summary
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There will be 2 arms;
1. Patients with BCR-ABL-positive hematopoiesis
2. CML patients with BCR-ABL activity inhibition under tyrosine kinase inhibitor (TKI) therapy
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Detailed Description
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To the best of investigators knowledge, there is a very limited number of studies in the literature and there is no study available comparing leukemic stem cells (CD45+/CD34+/CD38-/CD26+) in patients with BCR-ABL-positive hematopoiesis and CML patients with BCR-ABL activity inhibition under TKI therapy in Turkey. Therefore,for the first time, it is planned to evaluate the prognostic value of the amount of leukemic stem cells in CML and to tailor individual treatment options.
Newly diagnosed CML patients or patients with a previous diagnosis under follow-up with or without TKIs will be included in this study. The patients will be divided into two groups as follows:
Group 1: Patients with BCR-ABL-positive hematopoiesis (newly diagnosed CML patients, CML patients with leukocytosis, CML patients without a hematological and/or cytogenetic and/or molecular response, CML patients whose BCR-ABL status becomes negative and then positive) will be included.
Group 2: Patients with CML with BCR-ABL activity inhibition under TKI therapy (patients with major molecular response (MMR) and/or deeper response) will be included.
Peripheral blood samples from 30 patients and bone marrow aspiration samples from 20 patients will be collected for each group. A total of 100 patients will be included in the study. The number of bone marrow aspiration samples is limited to 20 patients for each group, as this method is more invasive with a higher rate of complications. Peripheral blood samples will be collected simultaneously in patients in whom bone marrow samples are collected. For an accurate examination, the bone marrow samples and the peripheral blood samples will be concomitantly analyzed for each individual patient. The presence and amount of CD45+/CD34+/CD38-/CD26+ leukemic stem cells will be analyzed using multicolor flow cytometry at Ankara University, Faculty of Medicine, Ibni Sina Hospital, Hematology Lab. The peripheral blood and bone marrow samples obtained at Hacettepe University and Ege University will be transferred to Ankara University, Faculty of Medicine, Ibni Sina Hospital, Hematology Lab in accordance with the codes of the Biological Material Transfer Agreement. As bone marrow aspiration and BCR-ABL molecular testing are routinely used in the diagnosis and follow-up of CML patients, these interventions pose no additional burden for the patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BCR-ABL-positive hematopoiesis
Patients with BCR-ABL-positive hematopoiesis (newly diagnosed CML patients, CML patients with leukocytosis, CML patients without a hematological and/or cytogenetic and/or molecular response, CML patients whose BCR-ABL status becomes negative and then positive) will be included.
No interventions assigned to this group
BCR-ABL activity inhibition under TKI
Patients with CML with BCR-ABL activity inhibition under TKI therapy (patients with MMR and/or deeper response) will be included.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ankara University
OTHER
Responsible Party
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Osman Ilhan
Prof.
Principal Investigators
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Osman Ilhan, Prof
Role: PRINCIPAL_INVESTIGATOR
Ankara University Medical Faculty Department of Hematology
Locations
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Ankara University
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Osman Ilhan, Prof
Role: primary
Other Identifiers
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CML-BCR-ABL-TKI
Identifier Type: -
Identifier Source: org_study_id
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