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

• Phase 1:

  • Total bilirubin ≤ 1.5 X institutional upper limit of normal
  • AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal
  • Creatinine Clearance ≥ 60mL/min

• Phase 2:

  • Total bilirubin ≤ 3 X institutional upper limit of normal
  • AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal
  • Creatinine Clearance ≥ 30mL/min
• 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
• Patients with acute promyelocytic leukemia (APL) confirmed with t(15;17)
• Patients with any history or active central nervous system (CNS) involvement with AML
• Blastic transformation of chronic myelogenous leukemia (CML)
• Previous allo-HSCT of any kind
• Hyperleukocytosis with > 50K blasts/μL.
• Prior treatment with indoximod
• Chronic steroid dependence (should have stopped all steroid supplementation 4 weeks prior to enrollment)
• History of prior treatment with anti-CTLA4 blocking antibody or similar antibodies
• Active, uncontrolled infection including known hepatitis B or C
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that per PI's judgment would limit compliance with study requirements
• Active autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids.
• History of any other active cancer diagnosis (treatment occurring more recently than three years prior) except for surgically resected basal cell carcinoma of the skin or surgically resected Ductal Carcinoma In Situ (DCIS) of the breast
• Pregnant women
• Known HIV-infected patients
• Active gastrointestinal disease causing ongoing malabsorption or obstruction such as, but not limited to, Crohn's disease, celiac sprue, tropical sprue, bowel obstruction, or extensive small bowel resection
• Unable to take medications by mouth
• History of allergic reactions attributed to any of the study drugs, compounds of similar chemical or biologic composition, or excipients with these agents
• Taking strong inhibitors/inducers of CYP3A4, CYP2D6 or CYP2C9