Evidence map›Paper›PMID 41383547›Full record

Trial reportBlood and lymphatic cancer : targets and therapy2025

Phase II Trial of an Orelabrutinib-Based Combination Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma.

Yajing Zhao, Xinguang Liu, Qiang He, Yafei Yu, Lei Xu, Caifeng Sun, Guoqiang Liu, Liang Wang, Ji Ma

Abstract readCase ReportsClinical Trial
In one paragraph

Trial report in Blood and lymphatic cancer : targets and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Yajing Zhao *Department of Hematology, Qilu Hospital of Shandong University, Jinan, Shandong, People's Republic of China.ORCID 0000-0002-6288-8688
Xinguang Liu *Department of Hematology, Qilu Hospital of Shandong University, Jinan, Shandong, People's Republic of China.
Qiang He *Department of Lymphoma, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, People's Republic of China.
Yafei YuDepartment of Hematology, Qilu Hospital of Shandong University, Jinan, Shandong, People's Republic of China.
Lei XuDepartment of Imaging, Shengli Oilfield Central Hospital, Dongying, Shandong, People's Republic of China.
Caifeng SunDepartment of Hematology, Shengli Oilfield Central Hospital, Dongying, Shandong, People's Republic of China.
Guoqiang LiuDepartment of Hematology, Shengli Oilfield Central Hospital, Dongying, Shandong, People's Republic of China.
Liang WangDepartment of Hematology, Shengli Oilfield Central Hospital, Dongying, Shandong, People's Republic of China.ORCID 0000-0001-9317-5253
Ji MaDepartment of Lymphoma, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Primary central nervous system lymphoma (PCNSL) is a rare, yet highly aggressive non-Hodgkin lymphoma confined to the central nervous system (CNS). High-dose methotrexate (HD-MTX) remains the baseline chemotherapy for newly-diagnosed PCNSL. Intensive chemotherapies combined with HD-MTX have improved patient outcomes. However, the substantial toxicities limited their applicability, especially among elderly patients with poor physical status. Optimal composition of induction and consolidation treatment are still warranted. Patients and methods: In this prospective single-arm phase II trial (ChiCTR2200061485), we evaluated the efficacy and safety of HD-MTX combined with rituximab and orelabrutinib, a second-generation BTK inhibitor with high CNS penetration, as induction therapy in newly diagnosed PCNSL. Twenty-two patients received up to six cycles of the combined induction therapy. Patients who achieved remission proceeded to non-randomized consolidation therapies with ASCT (autologous hematopoietic stem cell transplantation), WBRT (whole-brain radiotherapy), or orelabrutinib maintenance, based on patient eligibility and physician discretion. The primary endpoint was the centrally assessed response post-induction. Secondary endpoints included progression free survival (PFS), overall survival (OS), and safety. Results: Among the 22 enrolled patients, the overall response rate (ORR) at the end of induction therapy was 91.0%, including 9 patients (41.0%) with complete remissions (CRs), and 11 patients (50.0%) with partial remissions (PRs). With a median follow-up of 22.3 months (range 2.3-42.4 months), the 1-year and 2-year PFS rates were 66.6% and 59.2%, respectively; OS rates were 81.8% and 66.3%, respectively. Consolidation was performed in 15 patients: 5 underwent ASCT, 4 received WBRT, and 6 received maintenance orelabrutinib. The most common adverse effects were grade 1 anemia (45.5%). Grade ≥ 3 events included neutropenia (13.6%) and pneumonia (9.0%). Conclusion: The combination of HD-MTX, rituximab, and orelabrutinib demonstrates high response rates and manageable toxicity in newly diagnosed PCNSL, supporting further evaluation in randomized trials.

Indexed as

high-dose methotrexateorelabrutinibprimary central nervous system lymphomarituximab

Identifiers

PMID41383547
PMCPMC12691636

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.