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

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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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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