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

Summary

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 primary objective of the study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib.

Timeline

Start

2019-03-27

Primary completion

2021-11-26

Completion

2023-11-08

Outcome

Met primary endpoint

Stopped (Enrollment): “Slow accrual.”

paper nine (25.7%; 95% confidence interval 12.5-43.3) patients achieved primary endpoint of ≥35% spleen volume reduction (SVR) at end of cycle (EOC) 6 PMID 38838026 ↗

Publications

• Gupta V, Yacoub A, Mesa RA, Harrison CN, Vannucchi AM, Kiladjian JJ, Deeg HJ, Fazal S, Foltz L, Mattison RJ, Miller CB, Parameswaran V, Brown P, Hernandez C, Wang J, Talpaz M. Safety and efficacy of fedratinib in patients with myelofibrosis previously treated with ruxolitinib: primary analysis of FREEDOM trial. Leuk Lymphoma. 2024 Sep;65(9):1314-1324. doi: 10.1080/10428194.2024.2346733. Epub 2024 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fedratinib	Small molecule	400 mg	—

Indications