Studying How Genetic Differences Affect Azacytidine Treatment in Adults with Acute Myeloid Leukemia or Myelodysplastic Syndromes

What this Trial Is About

Researchers are investigating how to personalize the dosage of azacytidine, a common treatment for patients with acute myeloid leukemia AML and myelodysplastic syndromes MDS. The study aims to determine if adjusting doses based on each patients genetic makeup and individual characteristics can improve treatment outcomes and reduce toxicity. This is an open-label, non-randomized study involving patients receiving azacytidine as part of their standard care. Participants will receive azacytidine at the standard dose of 75 mgm daily for 7 days, repeated every 28 days. Alongside this, the study includes genetic testing using next-generation sequencing NGS to analyze enzymes affecting azacytidine metabolism CDA and dCK. Blood samples will be collected at multiple treatment cycles to measure drug levels and enzyme activity, using mathematical models to predict and personalize dosing. Throughout the study, patients will be monitored for treatment response, progression-free survival, and toxicities using standard criteria. Blood samples will be taken before and after treatment cycles to assess drug exposure and genetic markers. The study will last approximately two years, during which researchers will evaluate how genetics impact drug levels and side effects to potentially improve dosing strategies in the future.

Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies