Chronic Myelogenous LeukemiaNCT02146846
Population Pharmacokinetics of Imatinib in CML Patients in Iran
An observational study of Chronic Myelogenous Leukemia, run by Kerman University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- Imatinib
- How many people
- 170 participants
- Where
- 1 siteIran
- Study dates
- Oct 2012to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with approved diagnosis of chronic myeloid leukemia taking Imatinib as treatment
Who may be able to join
- patient in chronic phase of myeloid leukemia
- no liver and renal failure
Who cannot join
- multiple dug treatment
- previous treatment of interferon
- patients in blast or accelerated phase
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study then population pharmacokinetics parameters is determined.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- Imatinib
- Keywords
- cml
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Glivec
Patients with chronic myeloid leukemia who receive Imatinib as treatment
| Study group | Role | What they receive |
|---|---|---|
| Imatinib, CML | Patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of changes of AUC, trough Concentration from predicted values
The influence of patients' characteristic on the pharmacokinetics of Imatinib will be assessd.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerman University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehsan Mohajeri, Kerman University of Medical Sciences
- Investigators
- ehsan mohajeri, Ph.D., Study director, Department of pharmaceutics, Faculty of pharmacy, Kerman University of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146846
- Sponsor's protocol ID
- Kerman-001-FOPPT
- Status last verified
- Sep 2016
- First submitted
- 9 Apr 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Imatinib in CML Patients in Iran
- ClinicalTrials.gov ID
- NCT02146846
- Acronym / sponsor ID
- Kerman-001-FOPPT
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- cml
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Kerman University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib, CML | – | Drug: ImatinibPatients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with approved diagnosis of chronic myeloid leukemia taking Imatinib as treatment
Key inclusion criteria (2 listed)
- patient in chronic phase of myeloid leukemia
- no liver and renal failure
Key exclusion criteria (3 listed)
- multiple dug treatment
- previous treatment of interferon
- patients in blast or accelerated phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImatinibAlso: GlivecPatients with chronic myeloid leukemia who receive Imatinib as treatment | Drug | Imatinib, CML |
Primary outcome
Percent of changes of AUC, trough Concentration from predicted values
Time frame: 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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ehsan mohajeri, Ph.D. study director
Department of pharmaceutics, Faculty of pharmacy, Kerman University of medical sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myelogenous Leukemia, run by Kerman University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of changes of AUC, trough Concentration from predicted values (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.