A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML
Eligibility Criteria
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
Sites / Locations
- Augusta University
- University of Maryland
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1a
Phase 1b (CLOSED TO ACCRUAL)
Patients enrolled in this arm will receive standard induction and consolidation chemotherapy (7+3) with Indoximod (freebase formulation). These patients will additionally receive maintenance therapy with indoximod for 6 months after consolidation therapy. The indoximod dose will be studied in up to 4 dose levels. All current subjects will transition from indoximod freebase capsules over to indoximod HCL F2 tablets. All new subjects enrolled will also receive indoximod HCL F2 tablets.
Patients enrolled in this arm will receive standard induction and consolidation chemotherapy (7+3) with Indoximod (HCL F1 formulation). These patients will receive maintenance therapy with indoximod for 6 months after consolidation therapy. The indoximod dose will be studied in up to 4 dose levels.