Epacadostat Idarubicin and Cytarabine (EIC) in AML

  • STATUS
    Not Recruiting
  • participants needed
    18
  • sponsor
    University Hospital Inselspital, Berne
Updated on 22 January 2021
cytarabine
daunorubicin
idarubicin
anthracyclines

Summary

This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the anthracycline/cytarabine combination as first-line induction treatment in AML patients fit for intensive treatment

Description

Background and Rationale:

Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1). Indoleamine 2,3- dioxygenase 1 (IDO1) is a 403 amino acid cytosolic haem enzyme encoded by the INDO gene on human chromosome 8p22. IDO1 is responsible for the catabolism of the essential amino acid tryptophan (trp) to kynurenine (kyn) within immune cells and a subset of tumor cells resulting in inhibition of antitumor cell-mediated immune responses. Increased IDO activity correlates with lower CR rates and shorter OS in AML.

Objective

The primary objective is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the anthracycline/cytarabine combination as first-line induction treatment in AML patients fit for intensive Treatment.

Study Duration:

Phase I part will last from 3 to 18 months (permitting the enrolment of minimum of 3 and a maximum of 18 patients).

Details
Condition Acute myeloid leukemia
Treatment cytarabine, Idarubicin, Daunorubicin, Epacadostat
Clinical Study IdentifierNCT03444649
SponsorUniversity Hospital Inselspital, Berne
Last Modified on22 January 2021

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