NCT03959371

Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

Observational, Retrospective and Prospective Study on the Use of Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 620 (estimated)
• Sponsor: Margherita Maffioli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2017-04-11
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-05-22
• Last updated: 2019-05-22

Locations

12 sites across 1 country: Italy