AAML1331, A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All-Trans Retinoic Acid
Study ID: STU 102015-054
This is a non-randomized phase iii study that will use the aiDa 0493 as a historical control. our statistical design is a hybrid design that will allow us to determine if the experimental regimen is non-inferior or even superior to the best published results for pediatric aPL. The strategy of this study is to reduce or eliminate anthracycline exposure (and the associated toxicities) for newly diagnosed aPL patients depending on their risk group assignment.