Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia; a Multicenter, Observational Study

HIK-CAR-2021-04

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

2022-07-20

2024-08-01

2024-08-01

Recruiting

240

Inclusion Criteria: 1. Age ≥18 years 2. Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis 3. Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment 4. 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 5. Written informed consent Exclusion Criteria: 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. -

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2023-09-22