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Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas

NCT05681195 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-03

No results posted yet for this study

Summary

This study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymphoma (PCNSL) or isolated central nervous system relapse of B cell lymphoma (SCNSL). Assessments include how well people respond to this treatment, whether their disease gets better or worse, and their survival. Safety of this treatment and its side effects also will be assessed.

Conditions

Interventions

DRUG

Pemetrexed

Participants will receive 900 mg/m\^2 via IV infusion over 10 minutes every 3 weeks x 4-8 induction cycles (21 days per cycle) as part of the induction therapy.

DRUG

Zanubrutinib

Participants will receive 320 mg PO daily or dose-adjusted when given concomitantly with CYP3A4 inhibitor on Days 3-19 of each induction cycle x 4-8 cycles (21 days per cycle) as part of the induction therapy. For those on maintenance therapy, participants will receive 320 mg PO daily or dose-adjusted when given concomitantly with CYP3A4 inhibitor on Days 1-28 of each maintenance cycle (28 days per cycle) until the transplant (if applicable) or disease progression.

PROCEDURE

Autologous Stem Cell Transplant (ASCT)

ASCT will occur in participants who are candidates for this procedure according to standard of care institutional protocols

RADIATION

Whole Brain Radiation Therapy (WBRT)

WBRT will occur in participants who are candidates for this procedure but not candidates for ASCT according to standard of care institutional protocols

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Baptist Health South Florida

    lead OTHER

Principal Investigators

  • Yuliya Linhares, M.D. · Miami Cancer Institute at Baptist Health, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2028-02-29
Completion
2033-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05681195 on ClinicalTrials.gov