Zanubrutinib with Pola-R-CHP and Methotrexate for Secondary CNS Lymphoma

This study is looking at a new way to treat secondary central nervous system (CNS) lymphoma, a type of cancer that affects the brain and spinal cord. It combines a drug called zanubrutinib with a standard treatment called Pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone) and high-dose methotrexate. Researchers want to see how well this combination works and what side effects it might have. You could be eligible if you are at least 18 years old and have a confirmed diagnosis of large B-cell lymphoma. The main goal of this study is to find out how many participants experience dose-limiting toxicities (serious side effects) within the first 21 days. The study plans to enroll about 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll about 20 participants.
What's involved
Participants will take zanubrutinib capsules orally, either 160 mg twice a day or 320 mg once a day, starting with the second cycle of Pola-R-CHP therapy. They will also receive methotrexate, polatuzumab vedotin, rituximab, and cyclophosphamide as part of their standard care.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring dose-limiting toxicities is up to 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06730542

Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Juan P. Alderuccio, MD
~20 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:ZanubrutinibMethotrexatePolatuzumab VedotinRituximabCyclophosphamideDoxorubicin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing dose-limiting toxicities (DLTs)
Measured over Up to 21 days
CNS Lymphoma
1 sites across 1 states
Florida1
  • Juan P Alderuccio, MD · PRINCIPAL_INVESTIGATOR · University of Miami

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  • Number of participants experiencing dose-limiting toxicities (DLTs)Up to 21 days

    The number of participants experiencing dose-limiting toxicities (DLTs) after starting study therapy. Toxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.