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

• Status: Completed
• Trial end date: 2019-12-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NewLink Genetics Corporation
• Treatments: Cytarabine; Idarubicin; Tryptophan

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