A multicenter randomized phase II/III trial of salvage treatment for refractory primary central nervous system lymphoma using tirabrutinib: JCOG2314 (ReSTART)

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ID: 317770
2026
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Abstract
Primary central nervous system lymphoma (PCNSL) is an aggressive malignancy. Patients refractory to high-dose methotrexate-based induction therapy have an extremely poor prognosis. Although whole-brain radiotherapy (WBRT) is the standard salvage treatment and provides potent tumor control, early functional deterioration and late neurocognitive toxicity remain major concerns. A phase I/II trial on relapsed or refractory PCNSL demonstrated favorable efficacy and tolerability of tirabrutinib, a second-generation selective Bruton's tyrosine kinase inhibitor. Tirabrutinib's oral administration has enabled outpatient management. However, its clinical value for induction-refractory PCNSL remains uncertain. We designed a multicenter, randomized phase II/III trial (JCOG2314) to assess the non-inferiority of tirabrutinib to WBRT in overall survival and its potential to reduce functional deterioration and cognitive impairment. A total of 94 patients from 49 institutions will be enrolled over 4 years. The trial has been registered in the Japan Registry of Clinical Trials (study number: jRCT1031250645).
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Authors Kota Kawabata, Fumiharu Ohka, Ryuta Saito, Tsuyoshi Onoe, Hideyuki Harada, Takashi Sasayama, Hideaki Yokoo, Yoshiki Arakawa, Junki Mizusawa, Noriko Mitome, Keita Sasaki, Haruhiko Fukuda, Yoshitaka Narita
Journal japanese journal of clinical oncology
Year 2026
DOI
10.1093/jjco/hyag090
URL
https://doi.org/10.1093/jjco/hyag090
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