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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Augusta University
Augusta, Georgia, United States
University of Maryland
Baltimore, Maryland, United States
Safety assessed by development of RLT, AEs and laboratory parameters of indoximod.
Phase 1
Time frame: 6 months
Comparison of serum concentrations (Cmax/Steady State) of indoximod freebase and indoximod salt formulation.
Phase 1
Time frame: 6 months
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 on study to induction failure, relapse or death
Time frame: 2 years
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)
Characterize the pharmacokinetics (PK) of indoximod, idarubicin and cytarabine through analysis of blood samples
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IDO pathway inhibitor
IDO pathway inhibitor
Time frame: 6 months