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

No results posted yet for this study

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

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.

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730542 on ClinicalTrials.gov