Dynamic Changes in the Levels of sCD62L and SPARC in Chronic Myeloid Leukemia Patients During Imatinib Treatment

May 18, 2022 updated by: Mahmoud Mohamed Elkholy, Tanta University

Monitoring of Soluble L-selectin (sCD62L) and Secreted Protein Acidic Rich in Cysteine in Chronic Myeloid Leukemia Patients Treated by Imatinib

This study aims to monitor the levels of soluble L-selectin (sCD62L) and secreted protein acidic rich in cysteine (SPARC) in chronic phase chronic myeloid leukemia (CP-CML) patients at baseline and after three and six months of imatinib therapy and evaluated the effect of imatinib on their levels and correlated their levels to clinical and laboratory parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic myelogenous leukemia (CML) is a clonal myeloproliferative disorder characterized by the reciprocal t (9:22) chromosomal translocation. This rearrangement produces abnormal chromosome called Philadelphia chromosome carrying the chimeric BCR-ABL oncoprotein which encodes for tyrosine kinase (TK). The Break Point Cluster Region- Abelson (BCR-ABL) fusion oncoprotein activates the various downstream signaling pathways causing reduced hematopoietic cell differentiation, decreased apoptosis, enhance proliferation and survival of leukemic cells. CML remains incurable for the most part, and only allogeneic hematopoietic stem cell transplantation can eradicate and cure CML. This is probably because quiescent leukemic stem cells are resistant to tyrosine kinase inhibitors (TKIs).

Imatinib (IM) was the first tyrosine kinase inhibitor to receive approval by the Food and Drug Administration for the treatment of patients with CML-CP. It acts via competitive inhibition at the ATP - binding site of the BCR-ABL protein, which results in the inhibition of phosphorylation of proteins involved in signal transduction. It inhibits the BCR-ABL kinase.

L-selectin is a glycoprotein which is one of three members in a family of cell adhesion molecules called selectins. L-selectin is expressed on most leukocytes and it appears to play an important role in the early stages of leukocyte-endothelial cell interaction. L-selectin is a critical molecule for the leukocyte-endothelial cell interaction that results in migration of naïve T-cells into peripheral lymph nodes and inflammatory locales such as: tumor microenvironment.

Secreted Protein, Acidic Rich in Cysteine (SPARC) is a multi-functional matricellular glycoprotein with growth inhibitory and anti-angiogenic activity in some cell types. This protein has counter adhesive properties, has effects on cell shape, immune surveillance, angiogenesis and inhibits cell proliferation. SPARC is multifunctional calcium binding matricellular glycoprotein, participates in tissue remodeling, morphogenesis and bone mineralization and is secreted by different types of cells such as: osteoblasts, fibroblasts and endothelial cells. SPARC binds Vascular Endothelial Growth Factor (VEGF), preventing VEGF induced tyrosine phosphorylation of VEGFR1 and antagonizing its pro-angiogenic effects. The role of SPARC in tumor genesis appears to be cell-type specific due to its diverse function in given microenvironment.

sCD62L and SPARC analyzed using commercially available ELISA kit.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 31511
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed CP-CML patients were invited to be enrolled in this study. Patients were diagnosed according to ELN guidelines. Full patient history taken and proper information sheets completed for all participants.

Description

Inclusion Criteria:

  • Both sexes.
  • Newly diagnosed patient with chronic phase, Philadelphia chromosome positive (Ph+) CML.
  • Age ≥ 18 years.

Exclusion Criteria:

  • Patients in blastic or accelerated phase of chronic myeloid leukemia.
  • Previous treatment with Imatinib.
  • Pregnancy and lactation.
  • Severe hepatic dysfunction.
  • Kidney dysfunction.
  • Intolerant or incompliant to imatinib.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CP-CML patients
Twenty five newly diagnosed CP-CML patients. Plasma sCD62L and serum SPARC levels were measured using commercially available ELISA kits
Diagnostic test: ELISA kit
Sandwich ELISA kit for the accurate quantitative detection of sCD62L and SPARC in human plasma and serum samples.
Control
Ten matched controls were enrolled. Plasma sCD62L and serum SPARC levels were measured using commercially available ELISA kits
Diagnostic test: ELISA kit
Sandwich ELISA kit for the accurate quantitative detection of sCD62L and SPARC in human plasma and serum samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic changes of sCD62L and SPARC levels in CP-CML patients during imatinib treatment
Time Frame: Baseline and after three and six months of treatment
Monitoring the changes in sCD62L and SPARC levels at baseline and after three and six months of imatinib treatment
Baseline and after three and six months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations of sCD62L or SPARC levels with laboratory and clinical parameters
Time Frame: Baseline and after three and six months of treatment
Correlations of sCD62L or SPARC levels with BCR-ABL1%, sokal risk score, spleen size, age and white blood cells, neutrophils, monocytes and lymphocytes counts at baseline and after three and six months of imatinib treatment
Baseline and after three and six months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Mahmoud M Elkholy, Bachelor, Clinical Pharmacy Department, Faculty of Pharmacy, Al Salam University in Egypt
  • Principal Investigator: Sahar M El-Haggar, Ph D, Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
  • Principal Investigator: Maryan W Fahmi, Ph D, Medical oncology unit, Internal medicine Department, Faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

July 25, 2021

Study Completion (Actual)

December 28, 2021

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9093595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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