At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 454 enrolled
Drug / intervention
Azacitidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia
In Brief
A Phase 3 clinical trial evaluating Azacitidine and Pevonedistat for Myelodysplastic Syndrome and 2 related conditions. Completed, enrolled 454 participants across 242 sites in 20 countries.
Detailed Summary
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
CollaboratorsTakeda Development Center Americas, Inc.
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartNov 2017
Primary CompletionMay 2021
Study CompletionOct 2024
TodayJul 2026
First PostedAug 31, 2017
Enrollment StartNov 28, 2017
Primary CompletionMay 28, 2021
Study CompletionOct 14, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.8 years ago
Interventions
Azacitidinedrug
Azacitidine intravenous or subcutaneous formulation.
Pevonedistatdrug
Pevonedistat intravenous infusion.