Status:
RECRUITING
Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
Lead Sponsor:
Hikma Pharmaceuticals LLC
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
Detailed Description
This is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. In the study site, two cohorts will be identified amo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 1\. CML in accelerated phase (AP) at enrolment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis 2. CML in BP at enrolment 3. Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics.
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Key Trial Info
Start Date :
July 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05282108
Start Date
July 20 2022
End Date
November 1 2026
Last Update
March 26 2025
Active Locations (4)
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1
National Cancer Institute (NCI)
Cairo, Egypt, 11796
2
Ain Shams University Hospital
Cairo, Egypt
3
Nasser Institute
Cairo, Egypt
4
Tanta Oncology Center
Tanta, Egypt