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Zanubrutinib and Pemetrexed for Relapsed/Refractory CNS Lymphomas

This study is testing a combination of two drugs, zanubrutinib and pemetrexed, for people with central nervous system (CNS) lymphoma that has come back (relapsed) or hasn't responded to previous treatments (refractory). You would first receive both drugs together (induction therapy), followed by zanubrutinib alone (maintenance therapy). The study aims to see how well people respond to this treatment, if their disease improves or worsens, and how long they live. Researchers will also closely monitor any side effects to understand the treatment's safety. You may be eligible if you are 18 or older and have a confirmed diagnosis of primary CNS lymphoma or secondary CNS lymphoma that has spread to the brain or spinal cord.

Study design
This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive pemetrexed through an IV every 3 weeks for 4-8 cycles, and zanubrutinib by mouth daily for 4-8 cycles during induction. If you continue to maintenance therapy, you would take zanubrutinib daily. Some participants may also receive an autologous stem cell transplant or whole brain radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
The study measures the best overall response rate to induction therapy at 6 months.

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NCT05681195

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Baptist Health South Florida
~15 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:PemetrexedZanubrutinibAutologous Stem Cell Transplant (ASCT)Whole Brain Radiation Therapy (WBRT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Overall Response Rate (ORR) to Induction Therapy
Measured over 6 months

Conditions

Primary Central Nervous System Lymphoma
Secondary Central Nervous System Lymphoma
Relapsed Cancer
Refractory Cancer

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B-Cell Non-Hodgkin LymphomaPrimary Central Nervous System LymphomaSecondary Central Nervous System LymphomaHepatitis C Infection

Where it's being run

1 sites across 1 states
Florida1

Study leadership

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

Who to contact

Yuliya Linhares, M.D.
[email protected]
(786) 596-2000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The investigator or a designated associate is requested to advise the patients how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Females using hormonal contraception should use barrier methods in addition.
Male patients with a female partner of childbearing potential are eligible if abstinent, vasectomized, or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for up to one week after the last dose of zanubrutinib.
Female patients of childbearing potential must practice highly effective methods of contraception.
Male patients with female partners must be abstinent, vasectomized, or agree to the use of barrier contraception in combination with other methods. Acceptable contraception methods are included in the study protocol.
Patients using hormonal contraceptives (e.g., birth control pills or devices) must use a barrier method of contraception (e.g., condoms) as well. 9. For patients with Infectious disease, must have:

What this trial measures

  • Best Overall Response Rate (ORR) to Induction Therapy6 months

    Best ORR to induction therapy is defined as the best response between the start of induction therapy until the end of induction therapy based on the criteria set forth in "Report of an international workshop to standardize baseline evaluation and response criteria for primary CNS lymphoma" (2005).