A multicenter randomized phase II/III trial of salvage treatment for refractory primary central nervous system lymphoma using tirabrutinib: JCOG2314 (ReSTART).
A new trial tests whether a daily pill can match radiation therapy's effectiveness against brain lymphoma while sparing patients from severe long-term memory and thinking problems.
This trial protocol paper registers JCOG2314 (ReSTART), a multicenter randomized phase II/III trial assessing whether oral tirabrutinib (BTK inhibitor) is non-inferior to whole-brain radiotherapy in overall survival for induction-refractory primary CNS lymphoma, with 94 patients across 49 Japanese institutions planned over 4 years. The trial addresses a critical unmet need: avoiding devastating neurocognitive toxicity from WBRT in patients with refractory PCNSL.
What the study was
- Study design
- Randomized phase II/III trial protocol (registration paper)
- Population
- Induction-refractory primary CNS lymphoma patients from 49 Japanese institutions
- Sample size
- 94
- Category
- Treatment Innovation
- Maturity
- Exploratory
- Journal
- Japanese Journal of Clinical Oncology
Why it surfaced
Protocol paper for a well-designed phase II/III RCT of oral BTK inhibitor vs WBRT in refractory PCNSL — a critical unmet need with major quality-of-life implications. Tirabrutinib already showed phase I/II efficacy; this trial will determine standard-of-care. Deferred from 2026-06-19 run.
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