A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib — FREEDOM

Myelofibrosis Clinical Trial

Official 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

Status Completed

Clinical Trial Summary

Clinical Trial Description

This is Single-Arm, Open-Label Efficacy and Safety Trial 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. The spleen volume reduction at the end of Cycle 6 as the primary objective. The secondary objectives of the study are to further evaluate the safety and to assess and implement mitigation strategies for WE and for gastrointestinal (GI) adverse events. The study will be at multiple centers to provide access to a broad population and have assurance the results are likely to have general applicability. This is also conducted as an open-label study to collect efficacy and safety data with fedratinib use, no randomization or stratification will occur. ;

Study Design

Related Conditions & MeSH terms

Myelofibrosis
Polycythemia
Polycythemia Vera
Post-essential Thrombocythemia Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Primary Myelofibrosis
Thrombocythemia, Essential
Thrombocytosis

Clinical Trial Details

NCT number	NCT03755518
Study type	Interventional
Source	Celgene
Contact
Status	Completed
Phase	Phase 3
Start date	March 27, 2019
Completion date	November 8, 2023

View Details

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