Daunorubicin/Cytarabine Liposome +/- Gemtuzumab Ozogamicin for Adult Patients with Newly Diagnosed, Low-Intermediate Risk, FLT3-Wild Type, AML: A Pilot Study

Introduction: Liposomal-encapsulated cytarabine and daunorubicin (CPX-351 or Vyxeos) has been approved by the Food and Drug Administration (FDA) for use in the treatment of newly diagnosed therapy-related AML (tAML) and AML with myelodysplasia-related changes (AML-MRCs). This was based on results of a phase III study conducted in patients with secondary AML (Lancet JE et al. JCO 2018). Despite data that highlighted the advantage of CPX-351 for sAML, it is intuitively likely that this powerful drug is also suitable for non-sAML. The mechanism of action is applicable for every AML. The aim of this study is to evaluate the role of CPX-351 for patients with de novo low/ intermediate risk, FLT3-negative AML. While a definitive phase III study is planned, herein is described the pilot forerunner study.