Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

NCT ID: NCT03959371

Last Updated: 2019-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 620 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2021-12-31

Brief Summary

The RUXOREL-MF observational study includes patients with primary and post-essential thrombocythemia/post-polycythemia vera myelofibrosis (MF) being treated with the oral JAK1-/JAK2-inhibitor ruxolitinib in a "real world" setting. Patients are treated according to current indications in Italy (i.e., primary and secondary MF patients with intermediate-1, intermediate-2, and high risk IPSS (International Prognostic Scoring System) scores and symptomatic splenomegaly and/or systemic symptoms). Patients are treated at facilities pertaining to the regional Hematology Network of Lombardy (Rete Ematologica Lombarda) in Italy. Efficacy data, data related to infectious and vascular events, data related to second primary malignancies, data regarding disease progression/transformation, and molecular information in relationship to ruxolitinib treatment will be collected and analyzed.

Conditions

Myelofibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

Ruxolitinib

Observational study including patients with myelofibrosis being treated with ruxolitinib in a "real world" setting. Patients are treated according to current indications.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age >= 18 years
• Diagnosis of primary myelofibrosis diagnosis according to the WHO 2016 classification or post-essential thrombocythemia/post-polycythemia vera myelofibrosis according to the IWG-MRT 2008 classification
• Patients with an intermediate-1, intermediate-2, or high risk score according to the IPSS (International Prognostic Scoring System)
• Patients treated with ruxolitinib in accordance with current indications in Italy
• Patients eligible or ineligible to hematopoietic stem cell transplant or who have already undergone a hematopoietic stem cell transplant

Exclusion Criteria

• Diagnoses other than primary myelofibrosis or post-essential thrombocythemia/post-polycythemia vera myelofibrosis
• Patients treated with ruxolitinib having a platelet count at treatment initiation <50 x10^9/L
• Patients treated with ruxolitinib for conditions other than primary myelofibrosis or post-essential thrombocythemia/post-polycythemia vera myelofibrosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Margherita Maffioli

OTHER

Sponsor Role: lead

Responsible Party

Margherita Maffioli

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francesco Passamonti, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale di Circolo ASST Sette Laghi, Università dell'Insubria, Varese, Italy

Locations

ASST Papa Giovanni XXIII

Bergamo, , Italy

Site Status: RECRUITING

U.O. Ematologia, ASST Spedali Civili

Brescia, , Italy

Site Status: RECRUITING

U.S.D. Trapianti di Midollo Osseo, ASST Spedali Civili

Brescia, , Italy

Site Status: RECRUITING

U.O.C. di Ematologia Clinica, ASST Lecco

Lecco, , Italy

Site Status: RECRUITING

U.O. Ematologia, ASST Fatebenefratelli-Sacco

Milan, , Italy

Site Status: RECRUITING

U.O. Ematologia, Fondazione IRCCS Istituto Nazionale Tumori

Milan, , Italy

Site Status: RECRUITING

U.O. Ematologia, Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status: RECRUITING

U.O. Ematologia, Humanicas Cancer Center

Milan, , Italy

Site Status: RECRUITING

U.O. Ematologia, Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

U.O. Oncoematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status: RECRUITING

Clinica Ematologica, Ospedale San Gerardo

Monza, , Italy

Site Status: RECRUITING

Ospedale di Circolo, ASST Sette Laghi

Varese, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Margherita Maffioli, MD

Role: CONTACT

margherita.maffioli@asst-settelaghi.it

+39-0332-278281

Francesco Passamonti, MD

Role: CONTACT

francesco.passamonti@asst-settelaghi.it

+39-0332-393648

Facility Contacts

Maria Chiara Finazzi, MD

Role: primary

Mariella D'Adda, MD

Role: primary

Nicola Polverelli, MD

Role: primary

Michela Anghileri, MD

Role: primary

Maria Cristina Carraro, MD

Role: primary

Francesco Spina, MD

Role: primary

Marianna Caramella, MD

Role: primary

Marianna Rossi, MD

Role: primary

Simona Malato, MD

Role: primary

Alessandra Iurlo, MD

Role: primary

Elena Elli, MD

Role: primary

Margherita Maffioli, MD

Role: primary

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Other Identifiers

RUXOREL-MF

Identifier Type: -

Identifier Source: org_study_id