IRB #

STUDY00016429

Title

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission

Principal Investigator

Rachel Cook

Study Purpose

The purpose of this study is to compare the safety and effects of gilteritinib (ASP2215) to placebo on people whose acute myeloid leukemia (AML) in first complete remission.

Medical Condition(s)

Acute Myeloid Leukemia (AML)

Eligibility Criteria

Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have been diagnosed with AML, and
-You have a certain genetic mutation (called a FLT3 mutation) based on your diagnosis testing.

Age Range

18 - N/A

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug/placebo for up to 2 years or until:
• You decide you no longer want to participate
• You do not complete the procedures required
• You become pregnant or decide to father a child
• Your disease condition returns (relapses) or you begin taking a new anti-cancer therapy
• You experience unacceptable side effects
• You receive other treatments not allowed within the study, or become eligible for and decide to have a transplant
• Your investigatorstudy doctor feels it is no longer in your best interest to continue treatment
• Your investigatorstudy doctor has received new information about the study medicine in relation to safety or effectiveness, which may influence your willingness to participate in the study. If this happens, your investigator will tell you/your legal representative about it in a timely manner and discuss it with you as to whether you wish to continue in the study.
• The Sponsor may decide to stop the study without your consent
• You are lost to follow-up despite our reasonable efforts to locate you.

After you stop taking the study drug/placebo, you will enter the follow up period. The study staff will contact you in about 30 days to ask questions about your current treatments, medications you are taking, and new signs or symptoms. The study staff will continue to contact you every three months after that to ask questions about your current treatments and their effectiveness for long term follow up information.

It is anticipated that your participation in this study may take up to five years. However, it might be shorter if you experience any of the reasons mentioned above that would end your participation early.

Minors Included

No

Contact

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

Sponsor

Astellas Pharma Global Development, Inc. (APGD)

Recruitment End

01/01/2026

Compensation Provided

No


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