Phase 2 Study with Pevonedistat in combination with
Azacitidine targeting NEDD8-activating enzyme (NAE) in TP53
Mutant Untreated Acute Myeloid Leukemia patients ≥ 60 years
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.
Acute Myeloid Leukemia (AML)
-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
60 - n/a
Healthy Volunteers Needed
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.
Clinical Trials Information Line
Beat AML, LLC, a division of the Leukemia and Lymphoma Society, Inc
Supported by: Millennium Pharmaceuticals, Inc.