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

Acute Myeloid Leukemia Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02835729
• Other study ID #: NLG2106
• Status: Completed
• Phase: Phase 1
• Start date: July 2016
• Est. completion date: December 27, 2019

Study information

• Verified date: June 2020
• Source: Lumos Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 27, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Idarubicin
Chemotherapy
• Cytarabine
Chemotherapy
• Indoximod Freebase
IDO pathway inhibitor
• Indoximod HCL F1
IDO pathway inhibitor
• Indoximod HCL F2
IDO pathway inhibitor

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
NewLink Genetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum kynurenine and tryptophan levels	Characterize the pharmacodynamic (PD) effect of indoximod	2 years
Other	IDO expression by immunohistochemistry in diagnostic and follow-up bone marrow biopsy specimens		2 years
Other	IDO protein and mRNA expression in diagnostic and follow-up bone marrow aspirate samples		2 years
Other	Methylation status of the IDO promoter in diagnostic and follow up bone marrow aspiration samples		2 years
Primary	Safety assessed by development of RLT, AEs and laboratory parameters of indoximod.	Phase 1	6 months
Primary	Comparison of serum concentrations (Cmax/Steady State) of indoximod freebase and indoximod salt formulation.	Phase 1	6 months
Secondary	Measurable Residual Disease Rate		2 years
Secondary	Clinical response rate		2 years
Secondary	Duration of complete response		2 years
Secondary	Event free survival	Time on study to induction failure, relapse or death	2 years
Secondary	Cumulative incidence of relapse (CIR)		2 years
Secondary	Overall survival (OS)		2 years
Secondary	Proportion of AML patients who become eligible for bone marrow transplantation		2 years
Secondary	Frequency and severity of adverse events		2 years
Secondary	Pharmacokinetics: Serum concentrations (Cmax/Steady State)	Characterize the pharmacokinetics (PK) of indoximod, idarubicin and cytarabine through analysis of blood samples	6 months