NCT05883904

Real World Evidence of Fedratinib Effectiveness in MF

Observational Study Protocol REALFed - Real World Evidence of Fedratinib Effectiveness in Myelofibrosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 93 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter prospective and retrospective observational clinical study in patients with primary or post polycythemia vera or post essential thrombocythemia myelofibrosis to test the efficacy of fedratinib in the rea world. Participants will be managed according to the clinical practice of the participating Center. All Centers will be Italian Hematology Units belonging to the GIMEMA Organization in Italy.

Detailed description

This is a multicenter prospective and retrospective observational clinical study with the aim of assessing the efficacy of fedratinib upon AIFA approval in patients with primary myelofibrosis or post polycythemia vera or post essential thrombocythemia myelofibrosis. Patients must meet current diagnostic criteria of MF, according to the WHO (World Health Organization) classification version 5th or the ICC (International Consensus Conference) either published in 2022 or post- polycythemia vera and post-essential thrombocythemia myelofibrosis (according to the ICC classification 2022). Patients enter the study at diagnosis or already in follow-up, at any stage of disease, except if transformed to blast phase. Patients who received fedratinib after June 2022 (time of AIFA reimbursement in Italy) will be enrolled and will be included both those ruxolitinib-naïve and ruxolitinib-exposed.

Conditions

• Primary Myelofibrosis
• Post-polycythemia Vera Myelofibrosis
• Post-essential Thrombocythemia Myelofibrosis

Interventions

Type	Name	Description
DRUG	Fedratinib	Fedratinib administered after AIFA reimbusement approval

Timeline

• Start date: 2024-01-29
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-06-01
• Last updated: 2024-02-08

Locations

1 site across 1 country: Italy