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Celgene: FEDR-MF-001 Ph3b Fedratinib with INT/High Risk PMF, post-PV MF, post-ET MF - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how well the study drug, fedratinib, works for treating MF.

What is the Condition Being Studied?

Intermediate or high-risk primary myelofibrosis (PMF), Postpolycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)

Who Can Participate in the Study?

Adults who:
- Have a diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO)
- Have been treated with ruxolitinib for less than 3 months

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have laboratory assessments and other procedures done
- Have to take Vitamin B1, if your blood level decreases
- Get the study drug, fedratinib, once a day in 28 day-cycles

Study Details

Full Title
A Phase 3b, Multicenter, Single-Arm, Open-Label Efficacy and Safety Study of Fedratinib 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.
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00101624
NCT:NCT03755518
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698