Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

Sponsor
Margherita Maffioli
Study ID
NCT03959371
Status
Unknown

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 11, 2017
Status verified
May 2019
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
620 participants (estimated)

Primary Outcome Measure

Rate of infectious events after ruxolitinib exposure in myelofibrosis patients [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Related Studies