"Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"

Chronic Myeloid Leukemia, Chronic Phase Clinical Trial

Official title:

"Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05543161
• Other study ID #: Soh-Med-22-09-10
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2023

Study information

• Verified date: September 2022
• Source: Sohag University
• Contact: Rowida Eid, Clinical Pathology Specialist
• Phone: 01002019899
• Email: rowaida-muhammad-post[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic myeloid leukemia (CML) is a stem cell (SC) neoplasm which originates from an incomplete process of differentiation of the hematopoietic stem cells (HSCs) to the adult cells which lead to accumulation of their immature form into the BM and the peripheral blood. It is characterized by the reciprocal translocation. The resulting oncoprotein, BCR/ABL1, is considered essential for the initiation and manifestation of the disease . In CML, leukemic stem cell (LSC) supposedly resides within the CD45+/ CD34+/CD38-/Lin- fraction of the leukemic clone (3). However, normal hematopoietic SC also exhibit this phenotype so that additional markers are required to discriminate CML LSC from normal SC. CD34+/CD38-/Lin- CML LSC specifically co-express dipeptidylpeptidase IV(DPPIV=CD26). This enzyme disrupts LSC-niche interactions by degrading stroma derived factor-1 (SDF-1). Moreover, CD26 is a robust biomarker for the quantification and isolation of CML LSC (4). It was reported that CD26+ LSCs were significantly correlated with BCR-ABL1 transcript level at diagnosis and after three months of treatment with tyrosine kinase inhibitor (TKI) .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• : All suspected patients for CML diagnosis aged more than 18 years who presented with high white blood cells(WBCs) count , marked shift to left in peripheral blood with or without splenomegaly .

Exclusion Criteria:

• Patients on treatment or presence of blasts in peripheral blood sample.

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Ebian HF, Abdelnabi AM, Abdelazem AS, Khamis T, Fawzy HM, Hussein S. Peripheral blood CD26 positive leukemic stem cells as a possible diagnostic and prognostic marker in chronic myeloid leukemia. Leuk Res Rep. 2022 May 9;17:100321. doi: 10.1016/j.lrr.2022.100321. eCollection 2022. — View Citation

Lane SW, Scadden DT, Gilliland DG. The leukemic stem cell niche: current concepts and therapeutic opportunities. Blood. 2009 Aug 6;114(6):1150-7. doi: 10.1182/blood-2009-01-202606. Epub 2009 Apr 28. Review. — View Citation

Lee SA, Kim YR, Yang EJ, Kwon EJ, Kim SH, Kang SH, Park DB, Oh BC, Kim J, Heo ST, Koh G, Lee DH. CD26/DPP4 levels in peripheral blood and T cells in patients with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Jun;98(6):2553-61. doi: 10.1210/jc.2012-4288. Epub 2013 Mar 28. — View Citation

Waumans Y, Baerts L, Kehoe K, Lambeir AM, De Meester I. The Dipeptidyl Peptidase Family, Prolyl Oligopeptidase, and Prolyl Carboxypeptidase in the Immune System and Inflammatory Disease, Including Atherosclerosis. Front Immunol. 2015 Aug 7;6:387. doi: 10.3389/fimmu.2015.00387. eCollection 2015. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral Blood Dipeptidylpeptidase IV (CD26)	to detect CD26+ LSCs by flow cytometry for accurate diagnosis of CML patients from peripheral blood sample to reduce the need for Bone Marrow aspiration.	1 year