Status:
COMPLETED
Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt
Lead Sponsor:
Hikma Pharmaceuticals LLC
Conditions:
Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase
Eligibility:
All Genders
18+ years
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 myel...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 28 2020
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT03454503
Start Date
May 13 2018
End Date
December 28 2020
Last Update
February 23 2021
Active Locations (1)
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1
National Cancer Institute (NCI)
Cairo, Egypt, 11796