Clinical Epidemiology in Contemporary Patients With Myelofibrosis.

NCT06533813 | Recruiting

• 1 other identifier: ERNEST-3
• Study Type: observational
• Target: 617
• Locations: 6 countries
• Sites: 27

Brief Summary

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.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Overall survival according to the presence of cytopenias at diagnosis

  Obtained by medical health records normally filled out in clinical practice

  At diagnosis during the baseline

Secondary Outcomes (8)

• Frequency and types of cytopenias

  At baseline; 1 year follow-up.

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

  At baseline; 1 year follow-up.

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

  At baseline; 1 year follow-up.

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

  At baseline; 1 year follow-up.

• Incidence of secondary neoplasia, overall, by site and by presence of cytopenias and treatments received

  At baseline; 1 year follow-up.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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).

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of early/prefibrotic primary myelofibrosis
• Concurrent participation to interventional clinical trials in MF

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead
• GlaxoSmithKline: collaborator

Study Sites (27)

Hematology Center after Prof.R.H. Yeolyan

Yerevan, Armenia

RECRUITING

University Hospital Halle Department of Hematology/Oncology

Halle, Germany

NOT YET RECRUITING

University Medicine Hannover

Hanover, Germany

RECRUITING

University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center Minden UKRUB, University of Bochum

Minden, Germany

RECRUITING

A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia

Alessandria, 15121, Italy

RECRUITING

ASST Papa Giovanni XXIII, SC Ematologia

Bergamo, Italy

RECRUITING

Policlinico S. Orsola - Malpighi, Unità di Ematologia

Bologna, Italy

RECRUITING

Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di ematologia con Trapianto di midollo Osseo

Catania, Italy

RECRUITING

AOU Careggi di Firenze, Divisione di Ematologia

Florence, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia

Milan, Italy

RECRUITING

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Ematologia

Milan, Italy

RECRUITING

Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo

Milan, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II, Divisione di Ematologia

Naples, Italy

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità, SCDU Ematologia

Novara, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo, Divisione di Ematologia

Pavia, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore, UCSC Ematologia

Roma, Italy

RECRUITING

Policlinico Umberto I, Dipartimento Ematologia, Oncologia e Dermatologia

Roma, Italy

RECRUITING

A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U

Torino, 10126, Italy

NOT YET RECRUITING

Ospedale Cardinale G. Panico

Tricase, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma, Unità di Ematologia

Verona, Italy

RECRUITING

Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia

Vicenza, Italy

RECRUITING

Department of Hematology, University Hospital, Jagiellonian University Medical College

Krakow, Poland

RECRUITING

Department and Clinic of Haematology, Blood Neoplasms, and Bone Marrow Transplantation, Wroclaw Medical University

Wroclaw, Poland

RECRUITING

Department of Hematology and Bone Marrow Transplantation, Fundeni Clinical Institute

Bucharest, Romania

RECRUITING

Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) - Hospital Clinic

Barcelona, Spain

RECRUITING

Hematology and Hemotherapy Department, 12 de Octubre University Hospital

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• TIZIANO BARBUI, MD

  FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

  STUDY DIRECTOR

Central Study Contacts

TIZIANO BARBUI, MD

CONTACT

0352675134; tbarbui@fondazionefrom.it

FENILI

CONTACT

sperimentazioni@fondazionefrom.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 1, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

DE (3); AR (1); IT (18); PL (2); ES (2); RO (1)