IRB #

STUDY00017570

Title

A Phase 2 Study of Entospletinib in NPM1 mutant/FLT3 ITD
Wild Type AML Patients Age > 60 years

Principal Investigator

Uma Borate

Study Purpose

The purpose of this study is to determine the safety and acceptability of the experimental drug, entospletinib (ENTO, GS-9973), alone and in combination with standard Chemotherapy (Cohort A) or alone and in combination with Azacitidine (Aza, Vidaza) (Cohort B), that is approved by the US Food and Drug Administration (FDA) for MDS (a pre-leukemic condition) as well as a subset of AML subjects.

Medical Condition(s)

Acute Myeloid Leukemia (AML)

Eligibility Criteria

-Participating in the Beat AML umbrella study master protocol (reference IRB# 16475)
-Newly diagnosed with AML
-Age 60 years or older at time of diagnosis
-An NPM1 mutation but FLT3 ITD negative

Age Range

60 - n/a

Healthy Volunteers Needed

No

Duration of Participation

Study participation may include up to 5 years of study drug treatment and an additional 5 years after you stop taking the study drug for follow-up.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Beat AML, LLC, a division of the Leukemia and Lymphoma Society, Inc

Supported by: Gilead Pharmaceuticals

Recruitment End

01/01/2037

Compensation Provided

No


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