Comparing Generic Imatinib Carcemia and Glivec for Chronic Myeloid Leukemia in the Chronic Phase A Multicenter Observational Study on Effectiveness and Safety

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a generic version of Imatinib Carcemia4 compared to the brand-name drug Glivec4 in managing patients with chronic phase Chronic Myeloid Leukemia CML. This observational study aims to understand how these treatments perform in real-life settings over a 12-month period without additional visits or interventions beyond usual care. The study observes two groups of patients one receiving Carcemia and the other receiving Glivec. Both groups are followed and assessed during their regular medical care, with no extra treatments or visits imposed by the study. The aim is to compare outcomes such as response to treatment and safety between the two cohorts. Participants will be monitored for key outcomes including the proportion who achieve and maintain major molecular response after 12 months. Safety, progression-free survival, event-free survival, survival without blastic phase, overall survival, cytogenetic responses, deep molecular response, and treatment compliance will also be tracked. All assessments happen as part of routine care, with data collected over the one-year follow-up period.

Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia