Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
Juan P. Alderuccio, MD
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men and women ≥ 18 years of age on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place). 2. Patients must have histologic confirmation of large B-cell lymphoma (LBCL) defined by the World Health Organization (WHO) classification. All LBCL subtypes are acceptable. Note: Patients with prior treatment for indolent lymphoma are still eligible for participation as long as they did not receive anthracycline-based therapy. 3. Baseline 18-fluorodeoxyglucose (FDG)-positron emission tomography scan/compu…
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.
Location
- University of MiamiMiami, Florida