Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
NCT06730542 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-14
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.
Conditions
- CNS Lymphoma
Interventions
- DRUG
-
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.
- DRUG
-
Participants will receive Methotrexate as per standard of care (SOC).
- DRUG
-
Polatuzumab Vedotin
Participants will receive Polatuzumab Vedotin as per standard of care (SOC).
- DRUG
-
Participants will receive Rituximab as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
- DRUG
-
Participants will receive Cyclophosphamide as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
- DRUG
-
Doxorubicin
Participants will receive Doxorubicin as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
- DRUG
-
Participants will receive Prednisone as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
Sponsors & Collaborators
-
BeiGene
collaborator INDUSTRY -
Juan P. Alderuccio, MD
lead OTHER
Principal Investigators
-
Juan P Alderuccio, MD · University of Miami
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-17
- Primary Completion
- 2030-04-30
- Completion
- 2030-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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