RecruitingPhase 1NCT06730542

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


Sponsor

Juan P. Alderuccio, MD

Enrollment

20 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to is to determine the effects (good and bad) of Zanubrutinib in Combination with Pola-R-CHP and High-dose Methotrexate in patients with Secondary Central Nervous System (CNS) Lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of treatments — zanubrutinib (a targeted oral drug) added to a standard chemotherapy-immunotherapy regimen — for people with large B-cell lymphoma that has spread to or is at high risk of spreading to the brain (central nervous system lymphoma). **You may be eligible if...** - You are 18 or older - You have been diagnosed with large B-cell lymphoma (any subtype) - Your tumor shows up on a PET or CT scan as measurable disease - You have not previously received treatment with anthracycline-based chemotherapy **You may NOT be eligible if...** - You have had a prior organ transplant or stem cell transplant - You have active, uncontrolled infections or serious heart conditions - You are pregnant or breastfeeding - You have other significant health conditions that would make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanubrutinib

Zanubrutinib capsules will be self-administered orally by participants at a starting dose of 160 mg twice a day (BID) or 320 mg once a day (QD)\* at the beginning of Cycle 2 of Pola-R-CHP therapy.

DRUGMethotrexate

Participants will receive Methotrexate as per standard of care (SOC).

DRUGPolatuzumab Vedotin

Participants will receive Polatuzumab Vedotin as per standard of care (SOC).

DRUGRituximab

Participants will receive Rituximab as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.

DRUGCyclophosphamide

Participants will receive Cyclophosphamide as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.

DRUGDoxorubicin

Participants will receive Doxorubicin as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.

DRUGPrednisone

Participants will receive Prednisone as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06730542


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