Clinical trial · Observational
Effect of Pharmacogenetics on Imatinib Plasma Level and Response
Investigation of the Possible Role of Genetic Polymorphism in Certain Metabolizing Enzymes and Membrane Transporters on Both Plasma Level and Molecular Response of Imatinib in Patients With Chronic Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPLC-UV | Diagnostic Test | — | UNRESOLVED |
| PCR | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CML patients with MMR
- description
- CYP3A5\*3 , CYP2C8\*3 , ABCG2 421 C\>A and SLC22A1 1222A \> G SNPs on the plasma level by HPLC-UV and molecular response of imatinib by PCR
- interventionNames
- Diagnostic Test: PCR
- Diagnostic Test: HPLC-UV
- label
- CML patients without MMR
- description
- CYP3A5\*3 , CYP2C8\*3 , ABCG2 421 C\>A and SLC22A1 1222A \> G SNPs on the plasma level by HPLC-UV and molecular response of imatinib by PCR
- interventionNames
- Diagnostic Test: PCR
- Diagnostic Test: HPLC-UV
Primary outcomes (1)
- measure
- Major molecular response to imatinib
- timeFrame
- 12 months from starting the drug
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented hematological, cytogenetic and molecular diagnosis of Philadelphia positive CML * Imatinib treatment for at least 12 months Exclusion Criteria: * Poor compliance to treatment * identification of gene mutation(s) in the kinase domain of BCR- ABL1.
References
Publications (1)
- DERIVEDMangoura SA, Abdel-Raheem MH, Eltyb HA, Molla MS, Hussein AMR. Influence of CYP2C8*3 and ABCG2 C421A genetic polymorphisms on trough concentration and molecular response of imatinib in Egyptian patients with chronic myeloid leukemia. Cancer Chemother Pharmacol. 2024 Dec 23;95(1):12. doi: 10.1007/s00280-024-04723-y. PMID 39714624