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NCT05883904 Clinical Trial

Real World Evidence of Fedratinib Effectiveness in MF

Primary Myelofibrosis Clinical Trial

— REALFed  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05883904
Other study ID # MPN0123
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 29, 2024
Est. completion date January 2026

Study information
Verified date February 2024
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 00390670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 93
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients aged 18 years or older. - Patients diagnosed with primary myelofibrosis [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 who met the reimbursement criteria for fedratinib, in accordance with the AIFA (Agenzia Italiana del Farmaco) after June 2022. - Patients eligible or not for stem cell transplant (SCT) or patients already undergoing SCT. - Patients on non-JAKi cytoreductive treatment. - Patients with palpable splenomegaly at baseline of fedratinib treatment. - Informed consent signed, if applicable. Exclusion Criteria: - Diagnosis of MPN, unclassifiable, myelodysplastic/myeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera. - Blast phase of MF. - Patients with platelets <50 x10^9/L at baseline of fedratinib treatment. - Patients ruxolitinib-exposed for other diseases.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fedratinib
Fedratinib administered after AIFA reimbusement approval

Locations
Country Name City State
Italy Ematologia FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO Milano

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Splenic response Splenic response is defined as 50% palpatory reduction. 6 months
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