Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes

• Conditions: Patients Diagnosed as Chronic Meyloid Leukemia

• Registration Number: NCT04326933
• Lead Sponsor: Assiut University

Brief Summary

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..

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 Timeline

• Study First Submitted: 2019-11-21
• Study Start: 2020-01-01
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-19
• Last Update Posted: 2022-02-22
• Primary Completion: 2022-02-28
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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.
Follow up electrolytes as Na, K, Ca and P before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib)	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

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt