Clinical Epidemiology in Contemporary Patients With Myelofibrosis.

ConditionMyelofibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

About this trial

Multicenter retrospective and prospective European observational study. At each site, all consecutive patients with a 2016- or 2022 World Health Organization (WHO) confirmed diagnosis of myelofibrosis (MF) established from 01/01/2018 to 31/12/2027 will be enrolled into the study. Yearly follow-up updates will be scheduled until the end of data collection on 31/12/2028 or until the last available patient visit, whichever comes first. At least 1 year of follow-up will be ensured from the last patient enrolled.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of primary myelofibrosis (PMF) or secondary (i.e., post-ET/PV MF) myelofibrosis according to 2016- or 2022-WHO criteria ascertained between 01/01/2018 and 31/12/2027

Age ≥ 18 years

Signed informed consent where applicable, in line with current European General Data Protection Regulation (GDPR) directives

Disqualifiers

Diagnosis of early/prefibrotic primary myelofibrosis

Concurrent participation to interventional clinical trials in MF

Trial population

Patients with a 2016- or 2022-WHO confirmed diagnosis of MF established from 01/01/2018 to 31/12/2027 will be enrolled into the study. Patients with primary and secondary to ET and PV myelofibrosis, annotated for genetic and histological features, in relation to the presence of baseline (i.e., at MF diagnosis) or treatment-related cytopenias (i.e., reduced count of blood cells manifesting as anemia, thrombocytopenia and/or neutropenia).

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Overall survival according to the presence of cytopenias at diagnosis

Obtained by medical health records normally filled out in clinical practice

Time frame
At diagnosis during the baseline

Secondary outcomes

1

Frequency and types of cytopenias

Obtained by medical health records normally filled out in clinical practice

Time frame
At baseline; 1 year follow-up.
2

Treatments response and duration (according to modified IWG-MRT and ELN 2013 criteria, overall and by presence of cytopenias

Obtained by medical health records normally filled out in clinical practice

Time frame
At baseline; 1 year follow-up.
3

Incidence of major CV events (thrombosis and bleeding), overall and by presence of cytopenias and treatments received

Obtained by medical health records normally filled out in clinical practice

Time frame
At baseline; 1 year follow-up.
4

Incidence of disease progressions (MF accelerated phase, MF blast phase/acute myeloid leukemia (AML)), overall and by presence of cytopenias and treatments received

Obtained by medical health records normally filled out in clinical practice

Time frame
At baseline; 1 year follow-up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.