Zanubrutinib Combination Therapy for Central Nervous System Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByJuan P Alderuccio, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Miami

No Placebo Group

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for patients with secondary CNS lymphoma. Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis and may have to meet certain health standards.

Inclusion Criteria

I am at least 18 years old or the legal age of consent where the study is conducted.

My cancer has spread to my brain and other parts of my body.

My scans show active cancer that can be measured.

Exclusion Criteria

I have an ongoing autoimmune condition affecting my red blood cells or platelets.

I do not have any serious illnesses that would stop me from following the study's procedures.

I have a severe lung condition.

I am currently receiving treatment for another cancer.

I am currently being treated for a serious infection.

I am unable to make my own medical decisions.

I am not taking strong CYP3A inducers.

I have not had major surgery within the last 4 weeks.

I need treatment with warfarin or similar blood thinners.

I have not received a live vaccine within 28 days before starting the study drug.

My cancer is a type of brain lymphoma and hasn't spread outside the brain.

I do not have any uncontrolled heart conditions.

I do not have an active HIV, hepatitis B, or hepatitis C infection.

I have a severe bleeding disorder.

I cannot swallow pills or have major digestive issues.

Participant Groups

The study tests the effectiveness of Zanubrutinib combined with Pola-R-CHP (Rituximab, Cyclophosphamide, Doxorubicin, Prednisone) and high-dose Methotrexate in treating secondary CNS lymphoma.

1Treatment groups

Experimental Treatment

Group I: Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate GroupExperimental Treatment7 Interventions

Participants will be in this group for up to 2 years

Zanubrutinib is already approved in United States, China for the following indications:

🇺🇸 Approved in United States as Brukinsa for: