Clinical trial NCT03454503: Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt
Official title: Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase
Keywords: Imatinib
Generic Imatinib
Leukemia
Chronic myeloid leukemia
Philadelphia chromosome-positive
Chronic phase
Observational study
Switched patients
Tyrosine kinase inhibitor
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from 2 sites in Egypt

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

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

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients who achieve and maintain major molecular response (MMR)
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®)
timeFrame: 18 months
measure: Progression free survival (PFS)
timeFrame: 18 months
measure: Event free survival (EFS)
timeFrame: 18 months
measure: Survival without blastic phase (BP)
timeFrame: 18 months
measure: Overall survival (OS)
timeFrame: 18 months
measure: Complete cytogenetic response (CCgR)
timeFrame: 12 months
measure: Complete molecular response (CMR)
timeFrame: 12 months
measure: Health-Related Quality of Life (HRQoL)
timeFrame: 18 months
measure: Treatment compliance on generic Imatinib
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute (NCI)
Study officials:
References: