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Real World Evidence of Fedratinib Effectiveness in MF — REALFed  

Primary Myelofibrosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05883904
Study type Observational
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 00390670390528
Email p.fazi@gimema.it
Status Recruiting
Phase
Start date January 29, 2024
Completion date January 2026
View Details
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