What question did this study set out to answer?

To investigate if adding ibrutinib to the R-MVP regimen increases the complete response rate in patients with newly diagnosed PCNSL.

January 23, 2026

Ibrutinib in combination with rituximab, methotrexate, vincristine, and procarbazine (R-MVP/i) for newly diagnosed primary CNS lymphoma (PCNSL)

Key Points

To investigate if adding ibrutinib to the R-MVP regimen increases the complete response rate in patients with newly diagnosed PCNSL.
Single-center phase 2 clinical trial
30 patients with newly diagnosed PCNSL enrolled
Patients received the combination of ibrutinib, rituximab, methotrexate, procarbazine, and vincristine
Data on response rates and toxicities collected at follow-up
Median follow-up of 25.1 months
29 out of 30 patients achieved complete response or CRu, resulting in a complete response rate of 97%
No grade 5 toxicity observed; treatment well tolerated
Most common toxicities included thrombocytopenia, anemia, lymphopenia, and liver enzyme elevations
Median progression-free survival and overall survival not reached; 2-year progression-free survival of 84.2%

Abstract

Abstract Background High-dose methotrexate (MTX)-based chemotherapy is the mainstay of treatment of primary central nervous system lymphoma (PCNSL). Only ∼60% of patients achieve a complete response to first line therapy with frequent relapses. The Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib has shown promising antitumor activity in recurrent/refractory PCNSL. Methods: The goal of the current single-center phase 2 trial was to explore whether the addition of ibrutinib to the combination of rituximab, methotrexate, procarbazine, and vincristine ((R-MVP/i) increases complete response rate (CCR). Results Thirty newly diagnosed PCNSLs were enrolled; median age 69 (range 41-79), median ECOG = 1. 29 patients completed R-MVP/i, 1 withdrew consent after 2 cycles. A CR/CRu was achieved in 29 patients and a partial response in 1 for a CRR of 29/30 (97%, 95% CI : 83.3%, 99.8%)). Treatment was well tolerated with no grade 5 toxicity was observed. Eight patients experienced 13 grade 4 toxicities (lymphopenia (n = 3), neutropenia (n = 4), thrombocytopenia (n = 3) white cell count decrease (n = 3)). The most common toxicities were thrombocytopenia, anemia, lymphopenia and liver enzyme elevations. No Aspergillus or Pneumocystis infections occurred. No refractory disease was observed. For the 29 patients completing the trial, 19 received consolidation with cytarabine (Ara-C), 8 autologous stem cell transplant, 1 rituximab maintenance and 1 was observed without maintenance or consolidation. At a median follow up of 25.1 months (range 3.3-49.2), the median progression-free (PFS) and overall survival (OS) was not reached with a 2-year PFS of 84.2% (95% CI: 62.7%-93.9%). Conclusions R-MVP/i was well tolerated and associated with excellent disease control and survival.

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