Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes

Patients Diagnosed as Chronic Meyloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04326933
• Other study ID #: TKI In CML
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Patients Diagnosed as Chronic Meyloid Leukemia

Intervention

Drug:
• Tyrosine kinase Inhibitors (Imatinib & Nilotinib)
Administration of tyrosine kinase inhibitors (Imatinib in a dose of 400mg/day & Nilotinib in adose of 600mg/day)

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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
Primary	Follow up electrolytes as Na, K, Ca and P before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib)	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