IRB #

STUDY00018590

Title

[WIRB - IAA] Gilteritinib Monotherapy or in Combination with Decitabine in Elderly Untreated FLT3 mutated Acute Myeloid Leukemia With High and Low Variant Allele Frequency (VAF)

Principal Investigator

Uma Borate

Study Purpose

The purpose of this study is to determine the safety and acceptability of the experimental drug, gilteritinib, 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
-Genetic marker (FLT3 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. You will be followed for lifetime for survival, relapse and other outcomes.

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: Astellas Pharma Global Development, Inc. (APGD)

Recruitment End

01/01/2038

Compensation Provided

No


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