The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin.
A histologically or pathologically confirmed diagnosis of AML based on WHO classification with or without extramedullary disease except for central nervous system disease. ECOG performance status ≤ 2 Left ventricular ejection fraction (LVEF) ≥ 50% Female patients of childbearing potential must have a negative pregnancy test < 1 week prior to enrollment. Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
Patients receiving any other investigational agents or immunotherapy Patients who have received prior chemotherapy for AML with the exception of hydroxyurea or leukapheresis for leukocytosis; prior hypomethylating or immunomodulatory agents for MDS are allowed Previous allo-HSCT of any kind Active, uncontrolled infection including known hepatitis B or C Active autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids. History of any other active cancer diagnosis Pregnant women Known HIV-infected patients
