IRB #

STUDY00016962

Title

A Phase II Study to Assess the Efficacy of the Treatment of IDH2 Mutant AML with Targeted IDH2 Inhibition and Subsequent Response-Driven Addition of Hypomethylating Agent Therapy

Principal Investigator

Uma Borate

Study Purpose

The purpose of this study is to determine the safety and acceptability of the experimental drug, AG-221, alone and in combination with azacitidine (Vidaza) that is approved by the US Food and Drug Administration (FDA) for MDS (myelodysplastic syndrome, 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
-IDH2 mutation status

Age Range

60 - n/a

Healthy Volunteers Needed

No

Duration of Participation

Study participation may include up to 12 months of study drug treatment and 30 days after you stop taking the study drug.

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: Celgene

Recruitment End

01/01/2037

Compensation Provided

No


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