A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and previously treated with ruxolitinib

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511972-33-00

Acronym

FEDR-MF-002

Enrollment

144

Registered

2024-05-07

Start date

2019-08-05

Completion date

2025-07-23

Last updated

2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis

Brief summary

Spleen volume response rate (RR)

Detailed description

Symptom response rate (SRR), Spleen volume response rate (RR25)

Interventions

DRUGDANAZOL

DRUGBUSULFAN

DRUG-

DRUGPOMALIDOMIDE

DRUGFEDRATINIB

DRUGRUXOLITINIB

DRUGPEGFILGRASTIM

DRUGHYDROXYCARBAMIDE

DRUGPEGINTERFERON ALFA-2A

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Spleen volume response rate (RR)	—

Secondary

Measure	Time frame
Symptom response rate (SRR), Spleen volume response rate (RR25)	—

Countries

Austria, Belgium, Czechia, France, Germany, Hungary, Ireland, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026