IRB #

STUDY00018109

Title

Phase 2 Study with Pevonedistat in combination with
Azacitidine targeting NEDD8-activating enzyme (NAE) in TP53
Mutant Untreated Acute Myeloid Leukemia patients ≥ 60 years
of age

Principal Investigator

Uma Borate

Study Purpose

The purpose of this clinical trial is to determine the safety and tolerability of the experimental drug Pevonedistat in combination with Azacitidine (Vidaza). Azacitidine (Vidaza) 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
-Has TP53 mutation

Age Range

60 - n/a

Healthy Volunteers Needed

No

Duration of Participation

Study participation may include up to 2 years of study drug treatment with Pevonedistat. Once you stop taking Pevonedistat and complete the 30-day Follow-Up Visit, you will be followed for life for survival, relapse and other outcomes. This follow-up will be every 3 months.

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: Millennium Pharmaceuticals, Inc.

Recruitment End

01/01/2038

Compensation Provided

No


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