Leukemic Stem Cell Detection for Chronic Myeloid Leukemia Patients With Major Molecular Response

NCT04104035 | Unknown

• 1 other identifier: CML-BCR-ABL-TKI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-Center, national, non-drug, prospective cohort study Target patient number is 100 The amount of CD45+/CD34+/CD38-/CD26+ levels of chronic myeloid leukemia (CML) stem cells in CML patients with and without BCR-ABL hematopoiesis will be compared. There will be 2 arms;

1. 1.Patients with BCR-ABL-positive hematopoiesis
2. 2.CML patients with BCR-ABL activity inhibition under tyrosine kinase inhibitor (TKI) therapy

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic Myeloid Leukemia; BCR-ABL

Outcome Measures

Primary Outcomes (1)

• Detection of CML leukemic stem cells in both peripheral blood and bone marrow of CML patients

  To detect the leukemic stem cells using an accurate, simple, and accessible tool in CML patients

  1 day

Secondary Outcomes (1)

• Detection of CML leukemic stem cell in bone marrow of patients in whom BCR-ABL is negative in peripheral blood with TKIs

  1 day

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed CML patients or patients with a previous diagnosis under follow-up with or without TKIs will be included in this study.

You may qualify if:

• Newly diagnosed CML patients or patients with a previous diagnosis under follow-up with TKIs

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Osman Ilhan, Prof

  Ankara University Medical Faculty Department of Hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osman Ilhan, Prof

CONTACT

+905322534532; ilhan@ankara.edu.tr

Zehra Narli

CONTACT

+905556171054; zehranarli@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: August 13, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)