Interaction Between Gut Microbiota and Tyrosine Kinase Inhibitors in Defining the Clinical Outcomes of Patients With Chronic Myeloid Leukemia

What this Trial Is About

Researchers are studying the relationship between gut microbiome profiles and treatment outcomes in patients with Philadelphia positive Chronic Myeloid Leukemia (CML), a type of blood cancer. This research aims to explore how the gut microbiota may influence immune responses and the effectiveness of tyrosine kinase inhibitors (TKIs), the standard treatment for CML. The study also considers how gut microbiome imbalances might contribute to side effects and metabolic or inflammatory changes during treatment. This is an observational study where participants will provide biological samples, including stool and blood, for detailed analysis. Tests will include sequencing of the gut microbiome, markers of intestinal health and inflammation, immune cell profiling, and assessments of metabolic and inflammatory markers. No active treatment is administered as part of the study; instead, researchers monitor natural variations and responses related to gut microbiota. Participants will be involved in sample collection and undergo laboratory evaluations over a period of up to four years. The primary outcome is to identify distinct gut microbiome genotypes associated with responses to TKI therapy. Throughout the study, immune and metabolic markers will also be measured to understand their role in treatment outcomes. No restrictions on age beyond adulthood apply, and the study does not involve any intervention or placebo administration.

Interaction Between Gut Microbiota and TKIs in Defining the Clinical Outcomes of Patients With CML