Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt

Hikma

Status

Completed

Conditions

Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase

Treatments

Drug: Imatinib

Study type

Observational

Funder types

Industry

Identifiers

NCT03454503

CRC-EGY-2016-05

Details and patient eligibility

About

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

Full 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.

Enrollment

173 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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