NCT05681195 Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas
| NCT ID | NCT05681195 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Baptist Health South Florida |
| Condition | Primary Central Nervous System Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2028-02 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Any of the following diseases histologically confirmed: 1. Primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma with measurable disease 2. Cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease 3. Ocular lymphoma with histologic confirmation of ocular lymphoma and measurable intracranial tumor. Slit-lamp examination and vitreal or retinal biopsy will be done to confirm ocular lymphoma. 2. Karnofsky performance status (KPS) ≥ 30% (≥ 50% for patients ≥ 60 years-old) 3. Progressed during first-line chemotherapy and/or radiotherapy -OR- insufficient clinical response to previous therapy or relapsed after initial successful treatment OR unable to tolerate previous therapy defined as Grade 3+ acute kidney injury (AKI) and/or transaminase elevation according to CTCAE v 5.0 criteria preventing repeat treatment exposure OR prior glucarpidase use due to high dose methotrexate delayed clearance and/or toxicity OR