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Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera

NCT ID: NCT06516406

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1055 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-06

Study Completion Date

2032-05-31

Brief Summary

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The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The primary purpose is to determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, understood as long-term survival.

Detailed Description

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The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histological, cytogenetic, molecular, and radiological investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular. data on systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. The minimum planned duration of individual patient observation is 3 months and the planned duration of the study is 10 years.

Conditions

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Myelofibrosis Primary Myelofibrosis Secondary Myelofibrosis

Keywords

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Safety Efficacy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia vera who are being treated or have been treated with ruxolitinib therapy in accordance with normal clinical practice.
* Availability of data on clinical history prior to initiation of Ruxolitinib therapy
* Obtaining informed consent for data collection and processing

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Ospedaliera Annunziata

Cosenza, Calabria, Italy

Site Status RECRUITING

Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

Reggio Calabria, Calabria, Italy

Site Status RECRUITING

Università degli Studi di Napoli Federico II U.O.C. di Ematologia e Trapianti di midollo

Napoli, Campania, Italy

Site Status RECRUITING

IRCCS Policlinico Sant'Orsola

Bologna, Emilia-Romagna, Italy

Site Status RECRUITING

Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna

Ferrara, Emilia-Romagna, Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, Emilia-Romagna, Italy

Site Status RECRUITING

AUSL di Piacenza - Palazzine Medicine Specialistiche

Piacenza, Emilia-Romagna, Italy

Site Status RECRUITING

Dipartimento Oncoematologico - AUSL della Romagna

Ravenna, Emilia-Romagna, Italy

Site Status RECRUITING

Ospedale Infermi di Rimini

Rimini, Emilia-Romagna, Italy

Site Status RECRUITING

A.O.U. Integrata di Udine

Udine, Friuli Venezia Giulia, Italy

Site Status RECRUITING

A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"

Rome, Lazio, Italy

Site Status RECRUITING

Ospedale S. Eugenio

Rome, Lazio, Italy

Site Status RECRUITING

Ospedale Belcolle

Viterbo, Lazio, Italy

Site Status RECRUITING

IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST

Genoa, Liguria, Italy

Site Status RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Site Status RECRUITING

Ospedale San Gerardo

Monza, Lombardy, Italy

Site Status RECRUITING

Ospedale San Luigi Gonzaga - Regione Gonzole

Turin, Piedmont, Italy

Site Status RECRUITING

Department of Oncology, University of Torino

Turin, Piedmont, Italy

Site Status RECRUITING

Città della Salute e della Scienza

Turin, Piedmont, Italy

Site Status RECRUITING

A. O. Ordine Mauriziano di Torino

Turin, Piedmont, Italy

Site Status RECRUITING

Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari

Cagliari, Sardinia, Italy

Site Status RECRUITING

A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto

Catania, Sicily, Italy

Site Status RECRUITING

A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore

Pesaro, The Marches, Italy

Site Status RECRUITING

Policlinico S.Maria alle Scotte

Siena, Tuscany, Italy

Site Status RECRUITING

AOU di Padova

Padua, Veneto, Italy

Site Status RECRUITING

A.O.U. Integrata Verona

Verona, Veneto, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesca Palandri, MD, PhD

Role: CONTACT

Phone: +390512143044

Email: [email protected]

Facility Contacts

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Francesco Mendicino, MD

Role: primary

Bruno Martino, MD

Role: primary

Novella Pugliese, MD

Role: primary

Francesca Palandri, MD, PhD

Role: primary

Francesco Cavazzini, MD

Role: primary

Monica Crugnola, MD

Role: primary

Costanza Bosi, MD

Role: primary

Francesco Lanza, MD

Role: primary

Simona Tomassetti, MD

Role: primary

Mario Tiribelli, MD

Role: primary

Massimo Breccia, MD

Role: primary

Elisabetta Abruzzese, MD

Role: primary

Roberto Latagliata, MD

Role: primary

Roberto Lemoli, MD

Role: primary

Alessandra Iurlo, MD

Role: primary

Elena Elli, MD

Role: primary

Daniela Cilloni, MD

Role: primary

Eloise Beggiato, MD

Role: primary

Giulia Benevolo, MD

Role: primary

Daniela Cilloni, MD

Role: primary

Giovanni Caocci, MD

Role: primary

Giuseppe Palumbo, MD

Role: primary

Alessandro Isidori, MD

Role: primary

Monica Bocchia, MD

Role: primary

Gianni Binotto, MD

Role: primary

Massimiliano Bonifacio, MD

Role: primary

Other Identifiers

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RUX-MF

Identifier Type: -

Identifier Source: org_study_id