AML Clinical Trial
Official title:
Epacadostat With Cladribine and Cytarabine (ECC) in Relapsed / Refractory AML Patients Fit for Intensive Chemotherapy; a Phase I Study.
This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine chemotherapy in relapsed / refractory AML patients fit for intensive treatment
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 cladribine/cytarabine
chemotherapy in relapsed / refractory 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 24 patients).
;
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