Momelotinib Effectiveness in Myelofibrosis

NCT07249606 | Not Yet Recruiting

• 1 other identifier: MPN0325
• Study Type: observational
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief Summary

Observational study aimed at evaluating the use of momelotinib in patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) in a real-world setting.

Conditions

Myelofibrosis (MF)

Keywords

Myelofibrosis; momelotinib; real-world; post polycythemia; post essential thrombocythemia

Outcome Measures

Primary Outcomes (1)

• Efficacy of momelotinib in splenic response improving

  To assess the splenic response in terms of rate of patients with more or equal than 50% palpatory reduction compared to baseline at 6 months.

  Six months

Study Arms (1)

MF patients treated with momelotinib

Patients diagnosed with primary or post-polycythemia vera/post-essential thrombocythemia myelofibrosis treated with momelotinib according to clinical practice from AIFA authorization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for primary myelofibrosis or post polycythemia vera or post essential thrombocythemia at the Italian hemathology units with access to momelotinib. All participating centers belong to the GIMEMA network.

You may qualify if:

• Patients aged 18 years or older.
• Patients diagnosed with primary or post-polycythemia vera/post-essential thrombocythemia myelofibrosis start treatment with MMB according to clinical practice from AIFA authorization.
• Patients with palpable splenomegaly at baseline of momelotinib treatment.
• Informed consent signed, if applicable.

You may not qualify if:

• Diagnosis of MPN, unclassifiable, myelodysplastic/myeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera.
• Accelerated/blast phase of MF.
• Patients with platelets \<20 x10(9)/L at baseline of MMB treatment.
• Patients JAK inhibitors-exposed for other diseases apart from MF.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Francesco Passamonti

  Ematologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

+390670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

+390670390514; e.crea@gimema.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): April 2, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share