OncoMatch/Clinical Trials/NCT05681195
Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas
Is NCT05681195 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pemetrexed and Zanubrutinib for primary central nervous system lymphoma.
Treatment: Pemetrexed · Zanubrutinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Primary Central Nervous System Lymphoma
Non-Hodgkin Lymphoma
Tumor Agnostic
Prior therapy
Must have received: chemotherapy and/or radiotherapy — first-line
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 those who would have been glucarpidase candidates due to delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered or toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance) due to impaired renal function OR unable to receive high dose methotrexate induction on every 2 week +/- 3 days schedule due to deconditioning and/OR need for physical rehabilitation between the high dose methotrexate treatments
Cannot have received: pemetrexed (pemetrexed)
Prior treatment with pemetrexed or a Bruton's tyrosine kinase (BTK) inhibitor for lymphoma
Cannot have received: Bruton's tyrosine kinase inhibitor
Prior treatment with pemetrexed or a Bruton's tyrosine kinase (BTK) inhibitor for lymphoma
Cannot have received: chemotherapy, cytotoxic therapy, immunotherapy, radiation therapy or therapeutic protocols
Prior participation in chemotherapy, cytotoxic therapy, immunotherapy, radiation therapy or therapeutic protocols within 2 weeks of protocol treatment
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelets ≥ 75 x 10^9/L and no platelet transfusion within the past 14 days; Hemoglobin (Hgb) ≥ 8 g/dL and no RBC transfusion within the past 14 days
Kidney function
Creatinine Clearance (CrCl) > 45 mL/minute using Cockcroft-Gault formula
Liver function
ALT and AST ≤ 3 times the upper limit of normal; Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome
Adequate bone marrow and organ function demonstrated by: ANC ≥ 1.5 x 10^9/L; Platelets ≥ 75 x 10^9/L and no platelet transfusion within the past 14 days; Hemoglobin (Hgb) ≥ 8 g/dL and no RBC transfusion within the past 14 days; ALT and AST ≤ 3 times the upper limit of normal; Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome; Creatinine Clearance (CrCl) > 45 mL/minute using Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Miami Cancer Institute at Baptist Health, Inc. · Miami, Florida
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