Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT05883904
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05883904
Study Brief:
Protocol Section:
NCT05883904