Real-World Study of Patients with Chronic Myelogenous Leukemia Receiving Approved First or Second Line Tyrosine Kinase Inhibitor Therapy

What this Trial Is About

Researchers are gathering real-world data from patients with Philadelphia chromosome-positive chronic myelogenous leukemia in the chronic phase Ph-CML-CP who are treated with tyrosine kinase inhibitors TKIs approved for first or second line therapy. This registry study aims to collect evidence on the tolerability, safety, effectiveness, and patient-reported outcomes over a prospective follow-up period of 5 years to understand long-term treatment results in routine healthcare settings. Participants will be those receiving TKI treatments including asciminib, bosutinib, dasatinib, imatinib, or nilotinib as prescribed in standard medical care, either as initial therapy or after one prior TKI therapy. The study includes patients who began these treatments on or after specified dates and those continuing asciminib after participating in an interventional trial. There is no treatment allocation instead, patients are observed based on their current prescribed TKI therapy. During the 5-year follow-up, participants treatment continuation and discontinuation due to adverse events will be monitored, along with the occurrence of adverse events, treatment switches, molecular and hematological responses, survival outcomes, and patient-reported measures of health, symptoms, and medication adherence. Data will be collected from electronic medical records and claims data with patient consent, ensuring ongoing safety and effectiveness observations in real-world care up to 5 years.

A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy