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Clinical Trial
. 2025 May 5;6(3):191-202.
doi: 10.1158/2643-3230.BCD-24-0156.

High-Dose Methotrexate, Ibrutinib, and Temozolomide in the Treatment of Newly Diagnosed Primary CNS Lymphoma: A Multicenter, Prospective Phase II Study

Affiliations
Clinical Trial

High-Dose Methotrexate, Ibrutinib, and Temozolomide in the Treatment of Newly Diagnosed Primary CNS Lymphoma: A Multicenter, Prospective Phase II Study

Yan Gao et al. Blood Cancer Discov. .

Abstract

We report promising efficacy and good tolerability of Bruton tyrosine kinase (BTK) inhibitor ibrutinib in treatment of newly diagnosed PCNSL. Additionally, we explored the contribution of ctDNA profiling to predictive potential in this prospective study. The consistency of ctDNA clearance from CSF/plasma was associated with more sustained treatment response and survival.

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Conflict of interest statement

X. Hong reports other support from Nanjing Geneseeq Technology Inc. outside the submitted work. No disclosures were reported by the other authors.

Figures

Figure 1.
Figure 1.
PFS and OS by the Kaplan–Meier method. A, The 2-year PFS was 57.6% (95% CI, 49.0–66.2). B, The 2-year OS was 84.8% (95% CI, 78.6–91.0).
Figure 2.
Figure 2.
Swimmer plot of the best overall response assessed by investigators for the treatment duration for all patients.
Figure 3.
Figure 3.
Summary of clinical features and genomic alterations in samples of tumor tissue (A), CSF (B), and plasma (C) at baseline. “PD status” refers to whether disease progression occurred during induction therapy or consolidation therapy. PD, progressive disease; PR, partial response; SD, stable disease; SV, structural variant.
Figure 4.
Figure 4.
Dynamic monitoring of ctDNA in CSF and plasma during induction therapy and maintenance therapy. Nonresponders, patients who had stable disease or disease progression. Responders, patients who achieved a CR or partial response.

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