Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

Last updated: May 18, 2019
Sponsor: Margherita Maffioli
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Treatment

N/A

Clinical Study ID

NCT03959371
RUXOREL-MF
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >= 18 years

  • Diagnosis of primary myelofibrosis diagnosis according to the WHO 2016 classificationor post-essential thrombocythemia/post-polycythemia vera myelofibrosis according tothe IWG-MRT 2008 classification

  • Patients with an intermediate-1, intermediate-2, or high risk score according to theIPSS (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 havealready undergone a hematopoietic stem cell transplant

Exclusion

Exclusion Criteria:

  • Diagnoses other than primary myelofibrosis or post-essentialthrombocythemia/post-polycythemia vera myelofibrosis

  • Patients treated with ruxolitinib having a platelet count at treatment initiation <50x10^9/L

  • Patients treated with ruxolitinib for conditions other than primary myelofibrosis orpost-essential thrombocythemia/post-polycythemia vera myelofibrosis

Study Design

Total Participants: 620
Study Start date:
April 11, 2017
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • ASST Papa Giovanni XXIII

    Bergamo,
    Italy

    Active - Recruiting

  • U.O. Ematologia, ASST Spedali Civili

    Brescia,
    Italy

    Active - Recruiting

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

    Brescia,
    Italy

    Active - Recruiting

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

    Lecco,
    Italy

    Active - Recruiting

  • U.O. Ematologia, ASST Fatebenefratelli-Sacco

    Milan,
    Italy

    Active - Recruiting

  • U.O. Ematologia, Fondazione IRCCS Istituto Nazionale Tumori

    Milan,
    Italy

    Active - Recruiting

  • U.O. Ematologia, Grande Ospedale Metropolitano Niguarda

    Milan,
    Italy

    Active - Recruiting

  • U.O. Ematologia, Humanicas Cancer Center

    Milan,
    Italy

    Active - Recruiting

  • U.O. Ematologia, Ospedale San Raffaele

    Milan,
    Italy

    Active - Recruiting

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

    Milan,
    Italy

    Active - Recruiting

  • Clinica Ematologica, Ospedale San Gerardo

    Monza,
    Italy

    Active - Recruiting

  • Ospedale di Circolo, ASST Sette Laghi

    Varese, 21100
    Italy

    Active - Recruiting

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