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.
Study Type
OBSERVATIONAL
Enrollment
620
Observational study including patients with myelofibrosis being treated with ruxolitinib in a "real world" setting. Patients are treated according to current indications.
ASST Papa Giovanni XXIII
Bergamo, Italy
RECRUITINGU.O. Ematologia, ASST Spedali Civili
Brescia, Italy
RECRUITINGU.S.D. Trapianti di Midollo Osseo, ASST Spedali Civili
Brescia, Italy
RECRUITINGU.O.C. di Ematologia Clinica, ASST Lecco
Lecco, Italy
RECRUITINGU.O. Ematologia, ASST Fatebenefratelli-Sacco
Milan, Italy
RECRUITINGU.O. Ematologia, Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy
RECRUITINGU.O. Ematologia, Grande Ospedale Metropolitano Niguarda
Milan, Italy
RECRUITINGU.O. Ematologia, Humanicas Cancer Center
Milan, Italy
RECRUITINGU.O. Ematologia, Ospedale San Raffaele
Milan, Italy
RECRUITINGU.O. Oncoematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
RECRUITING...and 2 more locations
Rate of infectious events after ruxolitinib exposure in myelofibrosis patients
Time frame: Through study completion, an average of 1 year
Rate of vascular events after ruxolitinib exposure in myelofibrosis patients
Time frame: Through study completion, an average of 1 year
Spleen response rate
Time frame: At 3 and 6 months from ruxolitinib start
Rate of primary secondary malignancies
Time frame: Through study completion, an average of 1 year
Acute myeloid leukemia transformation rate
Time frame: Through study completion, an average of 1 year
Rate of infectious events according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL)
Association of rate of infectious events with driver mutational status
Time frame: Through study completion, an average of 1 year
Rate of vascular events according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL)
Association of rate of vascular events with driver mutational status
Time frame: Through study completion, an average of 1 year
Spleen response rate according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL)
Association of spleen response rate with driver mutational status
Time frame: Through study completion, an average of 1 year
Rate of primary secondary malignancies according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL)
Association of rate of primary secondary malignancies with driver mutational status
Time frame: Through study completion, an average of 1 year
Acute myeloid leukemia transformation rate according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL)
Association of acute myeloid leukemia transformation rate with driver mutational status
Time frame: Through study completion, an average of 1 year
Rate of infectious events according to the presence of additional mutations
Association of rate of infectious events with the presence of additional mutations
Time frame: Through study completion, an average of 1 year
Rate of vascular events according to the presence of additional mutations
Association of rate of vascular events with the presence of additional mutations
Time frame: Through study completion, an average of 1 year
Spleen response rate according to the presence of additional mutations
Association of spleen response rate with the presence of additional mutations
Time frame: Through study completion, an average of 1 year
Rate of primary secondary malignancies according to the presence of additional mutations
Association of rate of primary secondary malignancies with the presence of additional mutations
Time frame: Through study completion, an average of 1 year
Acute myeloid leukemia transformation rate according to the presence of additional mutations
Association of acute myeloid leukemia transformation rate with the presence of additional mutations
Time frame: Through study completion, an average of 1 year
Evaluation of overall survival after ruxolitinib start and, if applicable, discontinuation
Time frame: Through study completion, an average of 1 year
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