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May 27, 2025Investigational New DrugsOpen Access

Orelabrutinib combined with rituximab and high-dose methotrexate as induction therapy in newly diagnosed primary central nervous system lymphoma

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Authors

XXXibin XiaoSecond Affiliated Hospital of Zhejiang University YWYiqin WengNingbo No. 2 Hospital HJHua‐Wei JiangSouth China Normal University

Discussion

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Implication

Clinical trial reveals high response rates and favorable safety with orelabrutinib, rituximab, and methotrexate in primary central nervous system lymphoma, suggesting an effective induction strategy.

Key Points

To evaluate the efficacy and safety of orelabrutinib combined with rituximab and high-dose methotrexate as induction therapy for newly diagnosed primary central nervous system lymphoma.
Interventional clinical trial (NCT05600660) enrolling 28 patients with newly diagnosed disease between October 21, 2020, and October 22, 2024.
Patients received orelabrutinib, rituximab, and high-dose methotrexate every 3 weeks as induction therapy, followed by autologous hematopoietic stem cell transplantation and orelabrutinib maintenance.
Evaluated overall response rate (ORR) at the end of induction as the primary endpoint, alongside secondary endpoints of progression-free survival (PFS), overall survival (OS), and safety.
The overall response rate was 71.4% (95% CI, 51.3–86.8%), consisting of complete responses in 57.1% (n=16) and partial responses in 14.3% (n=4) of patients.
At a median follow-up of 21.6 months, the median PFS was 35.3 months (95% CI, 8.4–not evaluable) and median OS was not reached, with 2-year PFS and OS rates of 64.3% and 90.9%, respectively.
All 28 patients (100%) experienced adverse events, with grade 3 toxicities in 25.0% (leukopenia 17.9%, thrombocytopenia 3.6%, diarrhea 3.6%), and zero off-target Bruton's tyrosine kinase toxicities or treatment-related deaths.

Cite This Study

Xiao et al. (2025) studied this question.

synapsesocial.com/papers/6a6fe5e12163a0a01bc421e8 https://doi.org/10.1007/s10637-025-01548-1

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Implication

Clinical trial reveals high response rates and favorable safety with orelabrutinib, rituximab, and methotrexate in primary central nervous system lymphoma, suggesting an effective induction strategy.