IRB #

STUDY00018440

Title

Phase 2 Study of AG-120 combined with Azacitidine in
Previously Untreated AML Patients > 60 Years with an IDH1
Mutation

Principal Investigator

Uma Borate

Study Purpose

The purpose of this study is to determine the safety and acceptability of the experimental drug (AG-120) 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
-An R132 IDH1 mutation

Age Range

60 - n/a

Healthy Volunteers Needed

No

Duration of Participation

If your disease continues to be in remission and if you did not have any unacceptable side effects, study drug will be continued until relapse or an unacceptable side effect occurs. Patients who stopped therapy for unacceptable side effects will be followed until the side effect ended or is considered stable by the doctor. Also, regardless, all participants will be followed for 30 days after removal from study treatment.

Once you stop taking AG-120 and complete the 30-day Follow-Up visit, you will be followed for life time for survival, relapse and other outcomes. This follow-up will be every 3 months and may occur by phone contact or by review of medical records from your referring hospital where you are followed up in order to see how you are doing and whether you have started any new anti-cancer therapies.

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: Agios Pharmaceuticals

Recruitment End

01/01/2038

Compensation Provided

No


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