A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Inclusion Criteria:

- 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