NCT06730542

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Juan P. Alderuccio, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Zanubrutinib	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	Methotrexate	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	Rituximab	Participants will receive Rituximab as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
DRUG	Cyclophosphamide	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	Prednisone	Participants will receive Prednisone as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.

Timeline

• Start date: 2025-04-17
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2024-12-12
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study