Phase I Trial of Escalating Doses of the Bcl-2 Inhibitor Venetoclax in Combination with Daunorubicin/Cytarabine Induction and High Dose Cytarabine Consolidation in Previously Untreated Adults with Acute Myeloid Leukemia ( AML)

Background: Although daunorubicin/cytarabine ("3+7")-based chemotherapy (CT) regimens produce complete remission (CR) rates of approximately 70% in younger adults, about 30% require re-induction. Among those achieving CR, relapse after post-remission intensive CT or allogeneic transplant is common and limits cure. Venetoclax (VEN) is an orally available selective BCL-2 inhibitor that promotes mitochondrial-mediated apoptosis in myeloblasts...