Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes

• Sponsor: Assiut University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04326933
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 26.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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..

Condition or Disease	Intervention/Treatment	Phase
Patients Diagnosed as Chronic Meyloid Leukemia	Drug: Tyrosine kinase Inhibitors (Imatinib & Nilotinib)

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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Feb 28, 2022
• Anticipated Study Completion Date: Mar 31, 2022

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospital	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noha Mahmoud, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04326933
• Other Study ID Numbers: TKI In CML
• First Posted: Mar 30, 2020
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Imatinib Mesylate

Study Results

No Results Posted as of Feb 22, 2022