Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes

February 19, 2022 updated by: Noha Mahmoud, Assiut University

Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes in Relation to Hematologic Response in Patients With Chronic Phase Chronic Meyloid Leukemia: Assiut University Hospital Insight

Determine the effects of tyrosine kinase Inhibitors on liver enzymes and electrolytes in relation to hematologic response in patients with chronic phase chronic meyloid leukemia.. Assiut University Hospital insight..

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

CML is a myeloproliferative neoplasm with unique biological and clinical features.

CML accounts for 15_20% of newly diagnosed cases of leukemias among adults. CML can present in three clinical phases : chronic phase, accelerated phase and blast phase.

CML is characterized by prodction of a breakpoint cluster region abelson(BCR-ABL) fusion protein with ABL kinase activity. This is due to reciprocal translocation between chromosome 9 and 22.

Imatinib & Nilotinib, an ABL kinase inhibitors, which has revolutionized the CML therapy, are a selective tyrosine kinase inhibitors.

The aim of the study is to determine the changes of liver enzymes and electrolytes in relation to hematologic response during treatment period.

Study Type

Observational

Enrollment (Anticipated)

40

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
      • Assiut, Egypt
        • Assiut University Hospital

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed patients with chronic phase chronic meyloid leukemia.

Description

Inclusion Criteria:

  • Newly diagnosed patients with CML
  • Chronic phase CML
  • Normal hepatic and renal functions

Exclusion Criteria:

  • Blastic phase CML
  • Accelerated phase CML
  • Hepatic & renal impairment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow up liver enzymes as AST, ALT, ALP and GGT before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib).
Time Frame: 6 months
Changes happen in liver enzymes after a period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib) which are assessed by measuring liver enzymes as AST, ALT, ALP, GGT before starting treatment and during the period of treatment and the relation between these changes and the hematologic response to the treatment that is assessed by CBC and BCR-ABL Gene.
6 months
Follow up electrolytes as Na, K, Ca and P before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib)
Time Frame: 6 months
Changes happen in electrolytes after a period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib) which are assessed by measuring electrolytes levels before starting treatment and during the period of treatment and the relation between these changes and the hematologic response to the treatment that is assessed by CBC and BCR-ABL Gene
6 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Howaida A Nafady, Prof., Not Affiliated

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)

January 1, 2020

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 19, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKI In CML

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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