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

Part of paid clinical trials in Miami, Florida.

Sponsor
Juan P. Alderuccio, MD
Study ID
NCT06730542
Phase
PHASE1
Status
Recruiting
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Conditions

  • CNS Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — 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.
  • Methotrexate — DRUG
    Participants will receive Methotrexate as per standard of care (SOC).
  • Polatuzumab Vedotin — DRUG
    Participants will receive Polatuzumab Vedotin as per standard of care (SOC).
  • Rituximab — DRUG
    Participants will receive Rituximab as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
  • Cyclophosphamide — DRUG
    Participants will receive Cyclophosphamide as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
  • Doxorubicin — DRUG
    Participants will receive Doxorubicin as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
  • Prednisone — DRUG
    Participants will receive Prednisone as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.

Study Details

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.

Key Dates

Start date
Apr 17, 2025
Status verified
May 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group
    Participants will be in this group for up to 2 years

Primary Outcome Measure

Number of participants experiencing dose-limiting toxicities (DLTs) [ Time Frame: Up to 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Juan P Alderuccio, MD
[email protected]
+1 (347) 9312272
Juan P Alderuccio, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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