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Study identifier: NCT07350850 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL

Condition: PCNSL · Primary Central Nervous System Lymphoma  ·  Sponsor: Tongji Hospital

PhasePhase 2
Planned participants77
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The goal of this clinical trial is to evaluate the efficacy and safety of a four-drug combination regimen as first-line treatment for adults aged 18 years and older with newly diagnosed primary central nervous system lymphoma (PCNSL). The main questions it aims to answer are: Does the combination of pirtobrutinib, sintilimab, rituximab, and high-dose methotrexate achieve a higher complete response rate than standard treatment for newly diagnosed PCNSL? What is the safety and tolerability profile of this four-drug combination regimen? Researchers will compare the experimental four-drug combination to investigator-selected standard-of-care regimens (all based on high-dose methotrexate) to see if the experimental regimen improves complete response rate, progression-free survival, and overall survival while maintaining an acceptable safety profile. Participants will: Be assigned to either the experimental group or the standard treatment group based on their personal preference Receive 6 cycles of induction therapy (21 days per cycle) with their assigned treatment regimen Undergo regular clinical assessments, including contrast-enhanced brain MRI scans, blood tests, and cerebrospinal fluid examinations Complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, mid-treatment, end of treatment, and follow-up visits Receive optional consolidation or maintenance therapy based on their response to induction treatment Be followed for up to 2 years after completing treatmen…

This description comes directly from the study's public registry record.

Talk to the study team

Jia Wei, MD  ·  027-83663200  ·  jiawei@tjh.tjmu.edu.cn

Always discuss trial participation with your own doctor first.

Locations (4)

The First Affiliated Hospital of Fujian Medical UniversityXiamen, Fujian, ChinaRecruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, Hubei, ChinaRecruiting
China-Japan Union Hospital of Jilin UniversityChangchun, Jilin, ChinaRecruiting
Shanxi Provincial People's HospitalTaiyuan, Shanxi, ChinaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07350850