At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 120 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 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia
In Brief
A Phase 2 clinical trial evaluating Azacitidine and Pevonedistat for Myelodysplastic Syndromes and 2 related conditions. Completed, enrolled 120 participants across 59 sites in 12 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Canada, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartApr 2016
Primary CompletionSep 2019
Study CompletionJul 2021
TodayJul 2026
First PostedNov 20, 2015
Enrollment StartApr 14, 2016
Primary CompletionSep 4, 2019
Study CompletionJul 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.6 years ago
Interventions
Azacitidinedrug
Azacitidine intravenous or subcutaneous formulation.
Pevonedistatdrug
Pevonedistat intravenous infusion.