IRB #

STUDY00017569

Title

A Phase 2 Study of Entospletinib and Decitabine Targeting
Mutant TP53 and or Complex Karyotype in Patients with
Untreated Acute Myeloid Leukemia > 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 with Decitabine.

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
-Has either a TP53 mutation with or without complex karyotype or Complex Karyotype without TP53 mutation

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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