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

NewLink Genetics

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Indoximod HCL F1; Drug: Idarubicin; Drug: Cytarabine; Drug: Indoximod Freebase; Drug: Indoximod HCL F2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02835729

NLG2106

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Phase 1a

Experimental group

Description:

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.

Treatment:

Drug: Indoximod HCL F2

Drug: Cytarabine

Drug: Idarubicin

Drug: Indoximod Freebase

Phase 1b (CLOSED TO ACCRUAL)

Experimental group

Description:

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.

Treatment:

Drug: Cytarabine

Drug: Idarubicin

Drug: Indoximod HCL F1