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

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 combina

Trial Details

NCT ID

NCT07350850

Phase

PHASE2

Sponsor

Tongji Hospital

Status

RECRUITING

Cancer Type

Lymphoma

Interventions

• Pirtobrutinib, Sintilimab, Rituximab, Methotrexate
• Standard of Care (Investigator Selected)

Locations (sample)

• Xiamen, Fujian, China|24.47979,118.08187
• Wuhan, Hubei, China|30.58333,114.26667
• Changchun, Jilin, China|43.88,125.32278
• Taiyuan, Shanxi, China|37.86944,112.56028

Key Eligibility Criteria

• Age \>= 18 years.
• Voluntarily signed informed consent.
• ECOG Performance Status 0-3.
• Expected survival \> 3 months.

For full eligibility, visit ClinicalTrials.gov.

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