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.
Primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma with measurable disease
Cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease
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.
Karnofsky performance status (KPS) ≥ 30% (≥ 50% for patients ≥ 60 years-old)
Serious uncontrolled concurrent illness or comorbid condition
Other active systemic malignancy except for basal cell carcinoma of the skin, cervical carcinoma in situ or very low and low risk prostate cancer under observation. Patients with a remote history (3 years or more) of malignancy are eligible for the protocol in the absence of active disease
Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol
Unable to comprehend the study requirements or who are not likely to comply with the study protocol
Baptist Health South Florida
Lead sponsor
BeiGene
Collaborator