CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 202 enrolled
Drug / intervention
FEDRATINIB +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.

Search/NCT03952039
NCT03952039Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib

Celgene·interventional·Posted May 16, 2019·Updated Aug 28, 2025

In Brief

A Phase 3 clinical trial evaluating FEDRATINIB and Best Available Therapy (BAT) for Primary Myelofibrosis and 2 related conditions. Completed, enrolled 202 participants across 107 sites in 16 countries.

Detailed Summary

A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
CountriesAustralia, Austria, Belgium, China, Czechia, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom
CollaboratorsImpact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 16, 2019
Enrollment StartSep 9, 2019
Primary CompletionDec 15, 2022
Study CompletionJul 28, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.1 years ago

Interventions

FEDRATINIBdrug

A potent and selective inhibitor of JAK2 kinase activity

Best Available Therapy (BAT)drug

Best available therapy (BAT)