Myelofibrosis (MF)NCT07249606
Momelotinib Effectiveness in Myelofibrosis
An observational study of Myelofibrosis (MF), run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis (MF)
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2026to 2 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Real-world Observation of Momelotinib Effectiveness in Myelofibrosis (ROME)
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.
Read the detailed description
This is a multicenter prospective and retrospective observational clinical study in adult patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) being treated with momelotinib in a real-world setting. The aim of the study is to evaluate the efficacy of momelotinib in terms of splenic response. All patients are managed according to the clinical practice of the participating Center.
- Conditions
- Myelofibrosis (MF)
- Keywords
- Myelofibrosis, momelotinib, real-world, post polycythemia, post essential thrombocythemia
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start2 Jan 2026 (estimated)
- Primary completion2 Jan 2028 (estimated)
- Study completion2 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelofibrosis (MF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Passamonti, Principal investigator, Ematologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249606
- Sponsor's protocol ID
- MPN0325
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Observation of Momelotinib Effectiveness in Myelofibrosis (ROME)
- ClinicalTrials.gov ID
- NCT07249606
- Acronym / sponsor ID
- MPN0325
- Conditions
- Myelofibrosis (MF)
- Keywords
- Myelofibrosis, momelotinib, real-world, post polycythemia, post essential thrombocythemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 2 Jan 2026 (estimated)
- Primary completion
- 2 Jan 2028 (estimated)
- Study completion
- 2 Apr 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter prospective and retrospective observational clinical study in adult patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) being treated with momelotinib in a real-world setting. The aim of the study is to evaluate the efficacy of momelotinib in terms of splenic response. All patients are managed according to the clinical practice of the participating Center.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of momelotinib in splenic response improving
Time frame: Six months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Passamonti principal investigator
Ematologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis (MF), run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (+390670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of momelotinib in splenic response improving (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.