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Effect of Pharmacogenetics on Imatinib Plasma Level and Response

NCT03262974 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-10-27

No results posted yet for this study

Summary

Imatinib, the tyrosine kinase inhibitor, is used for treatment of Philadelphia positive chronic myeloid leukemia. Despite its efficacy and favorable pharmacokinetic profile, there is a large inter-individual variability in imatinib plasma concentrations, which may lead to treatment failure and disease progression. Polymorphisms in genes related to absorption, distribution, metabolism and excretion of imatinib may affect the bioavailability and consequently the response to the drug.

The study aims to investigate the possible effect of genetic polymorphisms in certain metabolizing enzymes \[CYP3A5\*3 (rs776746), CYP2C8\*3 (rs11572080 and rs10509681)\] and membrane transporters \[ABCB1 2677G\>T/A (rs2032582) and SLC22A1 1222A \> G (rs628031)\] by PCR on the plasma level (by HPLC-UV) and molecular response (MMR) of imatinib in patients with CML.

The study also aims to provide CML patients with a personalized treatment option, thereby probably improving the response and reducing the side effects.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DIAGNOSTIC_TEST

PCR

PCR

DIAGNOSTIC_TEST

HPLC-UV

HPLC-UV

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Safwat Mangoura · Pharmacology department, Faculty of Medicine, Assiut University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-29
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262974 on ClinicalTrials.gov