Chronic Myloid Leukemic Patients Treated With Tyrosine Kinase Inhibitor

NCT03907670 | Unknown DMC

• 1 other identifier: EAdam
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to assesse the levels of various biomarkers, specifically interleukin (IL)-6, platelet-derived microparticles (PDMPs), 11, 12 soluble vascular cell adhesion molecule 1 (sVCAM-1), transforming growth factor (TGF) β1, and sCTLA-4, in TKI-treated patients with CML. To measure the fluctuations in the levels of sCTLA-4, TGFβ1, and PDMPs, and to clarify the clinical significance of these biomarkers during TKI therapy in patients with CML..

Conditions

Chronic Phase Chronic Myelogenous Leukemia

Keywords

chronic myeloid leukemia; Tyrosine kinase inhibitors

Outcome Measures

Primary Outcomes (1)

• assessment of CML patients receiving tyrosine kinase inhibitors

  Assesse the levels of various biomarkers, especifically 1-interleukin (IL)-6, 2- platelet-derived microparticles (PDMPs),3- 17-20 soluble vascular cell adhesion molecule 1(sVCAM-1),4- Transforming growth factor (TGF) β1, and sCTLA-4, in TKI-treated patients with CML

  6 months

Study Arms (3)

CML patients who will receive imatinib

Patients with chronic myeloid leukemia newly diagnosed, who will receive Tyrosine Kinase inhibitor treatment (imatinib)measure the fluctuations in the levels of sCTLA-4, TGFβ1, and PDMPs, and to clarify the clinical significance of these biomarkers during TKI therapy in patients with CML

CML patients who will receive nilotinib

Patients with chronic myeloid leukemia newly diagnosed, who will receive Tyrosine Kinase inhibitor treatment(nilotinib)measure the fluctuations in the levels of sCTLA-4, TGFβ1, and PDMPs, and to clarify the clinical significance of these biomarkers during TKI therapy in patients with CML

CML patients who will receive dasatinib

Patients with chronic myeloid leukemia newly diagnosed, who will receive Tyrosine Kinase inhibitor treatment(dasatinib) measure the fluctuations in the levels of sCTLA-4, TGFβ1, and PDMPs, and to clarify the clinical significance of these biomarkers during TKI therapy in patients with CML

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

45 patients with chronic myeloid leukemia newly diagnosed, who will receive TKI treatment (imatinib, nilotinib, dasatinib

You may qualify if:

• Newly diagnosed CML patients
• Receive TKI treatment (imatinib, nilotinib, dasatinib) selected among those admitted to the investigator's hospital.
• Ageing group 20yr up to 80 yr.

You may not qualify if:

• CML patients who previously treated with TKI.
• Age below 20 yrs.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase; 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 Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: September 30, 2019

Record last verified: 2019-04