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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02835729
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Lumos Pharma ( NewLink Genetics Corporation )

Tracking Information
First Submitted Date  ICMJE July 11, 2016
First Posted Date  ICMJE July 18, 2016
Last Update Posted Date June 4, 2020
Study Start Date  ICMJE July 2016
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • Safety assessed by development of RLT, AEs and laboratory parameters of indoximod. [ Time Frame: 6 months ]
    Phase 1
  • Safety and tolerability assessed by development of AEs and laboratory parameters of indoximod + SOC therapy as compared to SOC therapy alone. [ Time Frame: 2 years ]
    Phase 2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2016)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
Official Title  ICMJE A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: Idarubicin
    Chemotherapy
  • Drug: Cytarabine
    Chemotherapy
  • Drug: Indoximod Freebase
    IDO pathway inhibitor
  • Drug: Indoximod HCL F1
    IDO pathway inhibitor
  • Drug: Indoximod HCL F2
    IDO pathway inhibitor
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Idarubicin
    • Drug: Cytarabine
    • Drug: Indoximod Freebase
    • Drug: Indoximod HCL F2
  • 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.
    Interventions:
    • Drug: Idarubicin
    • Drug: Cytarabine
    • Drug: Indoximod HCL F1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2020)
54
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
138
Actual Study Completion Date  ICMJE December 27, 2019
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02835729
Other Study ID Numbers  ICMJE NLG2106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lumos Pharma ( NewLink Genetics Corporation )
Study Sponsor  ICMJE NewLink Genetics Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lumos Pharma
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP