RT Journal Article
T1 Janus kinase inhibitor ruxolitinib in combination with nilotinib and prednisone in patients with myelofibrosis (RuNiC study): A phase Ib, multicenter study
A1 Ayala Díaz, Rosa María
A1 Martínez López, Joaquín
AB This phase Ib, non-randomized, open-label study evaluates the safety and tolerability of ruxolitinib in combination with nilotinib and prednisone in patients with naïve or ruxolitinib-resistant myelofibrosis (MF). A total of 15 patients with primary or secondary MF received the study treatment; 13 patients had received prior ruxolitinib treatment (86.7%). Eight patients completed seven cycles (53.3%) and six patients completed twelve cycles of treatment (40%). All the patients experienced at least one adverse event (AE) during the study (the most common AEs were hyperglycemia, asthenia, and thrombocytopenia), and 14 patients registered at least one treatment-related AE (the most common treatment-related AEs were hyperglycemia (22.2%; three grade 3 cases). Five treatment-related serious AEs (SAEs) were reported in two patients (13.3%). No deaths were registered throughout the study. No dose-limiting toxicity was observed. Four out of fifteen (27%) patients experienced a 100% spleen size reduction at Cycle 7, and two additional patients achieved a >50% spleen size reduction, representing an overall response rate of 40% at Cycle 7. In conclusion, the tolerability of this combination was acceptable, and hyperglycemia was the most frequent treatment-related AE. Ruxolitinib in combination with nilotinib and prednisone showed relevant clinical activity in patients with MF. This trial was registered with EudraCT Number 2016-005214-21.
PB wiley
SN 2688-6146
SN 2688-6146
YR 2023
FD 2023-04-16
LK https://hdl.handle.net/20.500.14352/103316
UL https://hdl.handle.net/20.500.14352/103316
LA eng
NO AyalaR,FernándezRA,García-GutiérrezV,Alvarez-LarránA,OsorioS,Sánchez-PinaJM,etal.Januskinaseinhibitorruxolitinibincombinationwithnilotinibandprednisoneinpatientswithmyelofibrosis(RuNiCstudy):AphaseIb,multicenterstudy.eJHaem.2023;4:401–409.https://doi.org/10.1002/jha2.685
NO Instituto de Salud Carlos III (España)
NO Instituto de Investigación Hospital 12 de Octubre (España)
NO Centro de Investigación Biomédica en Red de Cáncer
NO Novartis
DS Docta Complutense
RD 10 abr 2025