A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT02835729 |
Recruitment Status :
Completed
First Posted : July 18, 2016
Last Update Posted : June 4, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myeloid Leukemia | Drug: Idarubicin Drug: Cytarabine Drug: Indoximod Freebase Drug: Indoximod HCL F1 Drug: Indoximod HCL F2 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) |
Study Start Date : | July 2016 |
Actual Primary Completion Date : | October 25, 2019 |
Actual Study Completion Date : | December 27, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Phase 1a
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. |
Drug: Idarubicin
Chemotherapy Drug: Cytarabine Chemotherapy Drug: Indoximod Freebase IDO pathway inhibitor Drug: Indoximod HCL F2 IDO pathway inhibitor |
Experimental: Phase 1b (CLOSED TO ACCRUAL)
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.
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Drug: Idarubicin
Chemotherapy Drug: Cytarabine Chemotherapy Drug: Indoximod HCL F1 IDO pathway inhibitor |
- Safety assessed by development of RLT, AEs and laboratory parameters of indoximod. [ Time Frame: 6 months ]Phase 1
- Comparison of serum concentrations (Cmax/Steady State) of indoximod freebase and indoximod salt formulation. [ Time Frame: 6 months ]Phase 1
- Measurable Residual Disease Rate [ Time Frame: 2 years ]
- Clinical response rate [ Time Frame: 2 years ]
- Duration of complete response [ Time Frame: 2 years ]
- Event free survival [ Time Frame: 2 years ]Time on study to induction failure, relapse or death
- Cumulative incidence of relapse (CIR) [ Time Frame: 2 years ]
- Overall survival (OS) [ Time Frame: 2 years ]
- Proportion of AML patients who become eligible for bone marrow transplantation [ Time Frame: 2 years ]
- Frequency and severity of adverse events [ Time Frame: 2 years ]
- Pharmacokinetics: Serum concentrations (Cmax/Steady State) [ Time Frame: 6 months ]Characterize the pharmacokinetics (PK) of indoximod, idarubicin and cytarabine through analysis of blood samples
- Serum kynurenine and tryptophan levels [ Time Frame: 2 years ]Characterize the pharmacodynamic (PD) effect of indoximod
- IDO expression by immunohistochemistry in diagnostic and follow-up bone marrow biopsy specimens [ Time Frame: 2 years ]
- IDO protein and mRNA expression in diagnostic and follow-up bone marrow aspirate samples [ Time Frame: 2 years ]
- Methylation status of the IDO promoter in diagnostic and follow up bone marrow aspiration samples [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835729
United States, Georgia | |
Augusta University | |
Augusta, Georgia, United States, 30912 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 |
Responsible Party: | NewLink Genetics Corporation |
ClinicalTrials.gov Identifier: | NCT02835729 |
Other Study ID Numbers: |
NLG2106 |
First Posted: | July 18, 2016 Key Record Dates |
Last Update Posted: | June 4, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
AML |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Cytarabine Idarubicin Tryptophan Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |