Condition: PCNSL · Primary Central Nervous System Lymphoma · Sponsor: Tongji Hospital
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.
Jia Wei, MD · 027-83663200 · jiawei@tjh.tjmu.edu.cn
Always discuss trial participation with your own doctor first.
| The First Affiliated Hospital of Fujian Medical University | Xiamen, Fujian, China | Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, China | Recruiting |
| China-Japan Union Hospital of Jilin University | Changchun, Jilin, China | Recruiting |
| Shanxi Provincial People's Hospital | Taiyuan, Shanxi, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07350850