Population Pharmacokinetics of Imatinib in CML Patients in Iran

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02146846

Enrollment

170

Registered

2014-05-26

Start date

2012-10-31

Completion date

2017-07-31

Last updated

2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelogenous Leukemia

Keywords

cml

Brief summary

The purpose of this study is to determine population Pharmacokinetics and differences and variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in treatment of chronic myeloid leukemia patients in Iranian population.

Detailed description

patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study then population pharmacokinetics parameters is determined.

Interventions

DRUGImatinib

Patients with chronic myeloid leukemia who receive Imatinib as treatment

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* patient in chronic phase of myeloid leukemia * no liver and renal failure

Exclusion criteria

* multiple dug treatment * previous treatment of interferon * patients in blast or accelerated phase

Design outcomes

Primary

Measure	Time frame	Description
Percent of changes of AUC, trough Concentration from predicted values	Blood sampling are collected on atleast the 30th day of treatment at the following time: 1 hour before the dose and 1 hour after the dose	The influence of patients' characteristic on the pharmacokinetics of Imatinib will be assessd.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026