Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic PhaseNCT03454503
Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt
An observational study of Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase, run by Hikma Pharmaceuticals LLC at 1 site in Egypt.
Trial summary
The purpose of this observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in Egypt Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase
- What is being tested?
- Imatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 173 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2018to 28 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from 2 sites in Egypt
Who may be able to join
- First cohort (newly diagnosed patients):
- Age ≥18 years
- Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
- Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
- Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range
- Written informed consent
Show all 11Show fewer
- Second cohort (switched patients):
- Age ≥18 years
- Ph+ CML patients in CP currently treated with Glivec®, with or without the presence of other cytogenetic abnormalities at the time of switch
- Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range and serum creatinine ≤1.5 times the upper limit of the normal range
- Written informed consent
Who cannot join
- CML in accelerated phase (AP) at enrollment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis
- CML in BP at enrollment
- Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt
The purpose of this observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in Egypt
Read the detailed description
An observational, multi-center, prospective cohort study to assess the effectiveness and safety of generic Imatinib (Carcemia®) in patients with Ph+ CML who are newly diagnosed or patients who will be switched from the reference product (Glivec® ) to Carcemia® where treatment will be prescribed by the investigator in accordance with clinical practice where no visits or intervention(s) additional to the daily practice will be performed.
Eligible Ph+ CML patients in both cohorts will be followed up for a total of 18 months.
- Being tested
- Imatinib
- Keywords
- Imatinib, Generic Imatinib, Leukemia, Chronic myeloid leukemia, Philadelphia chromosome-positive, Chronic phase, Observational study, Switched patients, Tyrosine kinase inhibitor
- Medical subject headings
- Leukemia, 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 Carcemia®
Film coated tablet contains 400 mg imatinib (as mesilate)
| Study group | Role | What they receive |
|---|---|---|
| First cohort | Newly diagnosed patients Receives: Drug: Imatinib | |
| Second cohort | Patients switched from reference product (Glivec® ) Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve and maintain major molecular response (MMR)
Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%
Measured: 12 months
Secondary outcomes (9)
Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®)
Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
Measured: 18 months
Progression free survival (PFS)
Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.
Measured: 18 months
Event free survival (EFS)
Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint
Measured: 18 months
Survival without blastic phase (BP)
Proportion of CML patients who will not experience blastic phase (BP) from enrollment to 18 months study endpoint.
Measured: 18 months
Overall survival (OS)
Proportion of CML patients who will not die till 18 months study endpoint.
Measured: 18 months
Complete cytogenetic response (CCgR)
Proportion of CML patients who will achieve no Ph+ metaphases at 12 months study endpoint by conventional cytogenetics and/or FISH test.
Measured: 12 months
Complete molecular response (CMR)
Proportion of CML patients who will achieve undetectable BCR-ABL mRNA transcripts by RQ-PCR test in two consecutive blood samples of adequate quality.
Measured: 12 months
Health-Related Quality of Life (HRQoL)
Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits
Measured: 18 months
Treatment compliance on generic Imatinib
Evaluated by identifying the frequency of not taking the medications as prescribed and the reasons. The decision on non-compliance is based on the treating physician's judgment.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start13 May 2018
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic PhaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454503
- Sponsor's protocol ID
- CRC-EGY-2016-05
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2018
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt
- ClinicalTrials.gov ID
- NCT03454503
- Acronym / sponsor ID
- CRC-EGY-2016-05
- Keywords
- Imatinib, Generic Imatinib, Leukemia, Chronic myeloid leukemia, Philadelphia chromosome-positive, Chronic phase, Observational study, Switched patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 13 May 2018 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 6 Mar 2018 (actual)
- 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 observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in Egypt
Detailed description
An observational, multi-center, prospective cohort study to assess the effectiveness and safety of generic Imatinib (Carcemia®) in patients with Ph+ CML who are newly diagnosed or patients who will be switched from the reference product (Glivec® ) to Carcemia® where treatment will be prescribed by the investigator in accordance with clinical practice where no visits or intervention(s) additional to the daily practice will be performed.
Eligible Ph+ CML patients in both cohorts will be followed up for a total of 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First cohort | – | Drug: ImatinibNewly diagnosed patients |
| Second cohort | – | Drug: ImatinibPatients switched from reference product (Glivec® ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from 2 sites in Egypt
Key inclusion criteria (11 listed)
- Age ≥18 years
- Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
- Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
- Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range
- Written informed consent
Key exclusion criteria (3 listed)
- CML in accelerated phase (AP) at enrollment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis
- CML in BP at enrollment
- Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics
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: Carcemia®Film coated tablet contains 400 mg imatinib (as mesilate) | Drug | First cohort, Second cohort |
Primary outcome
Proportion of patients who achieve and maintain major molecular response (MMR)
Time frame: 12 months
Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%
9 secondary outcomes
Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®)
Time frame: 18 months
Progression free survival (PFS)
Time frame: 18 months
Event free survival (EFS)
Time frame: 18 months
Survival without blastic phase (BP)
Time frame: 18 months
Overall survival (OS)
Time frame: 18 months
Complete cytogenetic response (CCgR)
Time frame: 12 months
Complete molecular response (CMR)
Time frame: 12 months
Health-Related Quality of Life (HRQoL)
Time frame: 18 months
Treatment compliance on generic Imatinib
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase, run by Hikma Pharmaceuticals LLC at 1 site in Egypt.
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 11 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: finished, as of the sponsor's last update on 23 Feb 2021. 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients who achieve and maintain major molecular response (MMR) (time frame: 12 months). 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 23 Feb 2021.