Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Patients Diagnosed as Chronic Meyloid Leukemia

Intervention / Treatment
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* Drug: Tyrosine kinase Inhibitors (Imatinib & Nilotinib)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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). | 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) | 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 |