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

A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

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.

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