Acute Myeloid Leukemia Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT02835729

Recruitment Status:

Completed

Sponsor:

NewLink Genetics Corporation

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There are 2 Locations for this study

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Augusta University
Augusta Georgia, 30912, United States
University of Maryland
Baltimore Maryland, 21201, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT02835729

Recruitment Status:

Completed

Sponsor:


NewLink Genetics Corporation

How clear is this clinincal trial information?

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