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

NCT02835729

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
  • Official Title: A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Clinical Trial IDs

  • ORG STUDY ID: NLG2106
  • NCT ID: NCT02835729

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
IdarubicinPhase 1a
CytarabinePhase 1a
Indoximod FreebasePhase 1a
Indoximod HCLPhase 1b

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Phase 1aExperimentalPatients 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.
  • Idarubicin
  • Cytarabine
  • Indoximod Freebase
Phase 1bExperimentalPatients enrolled in this arm will receive standard induction and consolidation chemotherapy (7+3) with Indoximod (HCL 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.
  • Idarubicin
  • Cytarabine
  • Indoximod HCL

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety assessed by development of RLT, AEs and laboratory parameters of indoximod.
Time Frame:6 months
Safety Issue:
Description:Phase 1

Secondary Outcome Measures

Measure:Measurable Residual Disease Rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Clinical response rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Duration of complete response
Time Frame:2 years
Safety Issue:
Description:
Measure:Event free survival
Time Frame:2 years
Safety Issue:
Description:Time on study to induction failure, relapse or death
Measure:Cumulative incidence of relapse (CIR)
Time Frame:2 years
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:2 years
Safety Issue:
Description:
Measure:Proportion of AML patients who become eligible for bone marrow transplantation
Time Frame:2 years
Safety Issue:
Description:
Measure:Frequency and severity of adverse events
Time Frame:2 years
Safety Issue:
Description:
Measure:Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Time Frame:6 months
Safety Issue:
Description:Characterize the pharmacokinetics (PK) of indoximod, idarubicin and cytarabine through analysis of blood samples

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NewLink Genetics Corporation

Trial Keywords

  • AML

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