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oai:repisalud.isciii.es:20.500.12105/231162025-04-08T07:30:32Zcom_20.500.12105_2173com_20.500.12105_2051com_20.500.12105_15322col_20.500.12105_19597col_20.500.12105_16938col_20.500.12105_16984

00925njm 22002777a 4500 dc Ayala, Rosa author Fernández, Rafael Alonso author García-Gutiérrez, Valentín author Alvarez-Larrán, Alberto author Osorio, Santiago author Sánchez-Pina, Jose M author Carreño-Tarragona, Gonzalo author Álvarez, Noemi author Gómez-Casares, María Teresa author Duran, Antonia author Gorrochategi, Julian author Hernández-Boluda, Juan Carlos author Martinez-Lopez, Joaquin author 2023-04-16 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. EJHaem . 2023;4(2):401-409. 10.1002/jha2.685 2688-6146 EJHaem 37206258 https://hdl.handle.net/20.500.12105/23116 Janus kinase inhibitor ruxolitinib in combination with nilotinib and prednisone in patients with myelofibrosis (RuNiC study): A phase Ib, multicenter study