Zanubrutinib Monotherapy in Relapsed/Refractory Central Nervous System Lymphoma

Exclusion Criteria

• •1. Patients with SCNSL actively receiving treatment for extra-CNS disease
• •2. Concurrently using other approved or investigational antineoplastic agents
• •3. Prior chemotherapy, targeted therapy, or radiation therapy within 4 weeks
• •4. Prior exposure to a BTK inhibitor
• •5. Concurrently using more than 8mg of dexamethasone daily or the equivalent
• •6. History of other active malignancies within 2 years of study entry
• •7. Major surgery within 4 weeks of screening or not recovered from the side effects of such surgery
• •8. Known to have human immunodeficiency virus (HIV) infection
• •9. Known to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests
• •10. Active infection systemic including infections requiring oral or intravenous antimicrobials
• •11. Currently active clinically significant cardiovascular disease
• •12. QTcF \> 480 msecs or other significant electrocardiogram (ECG) abnormalities
• •13. Unable to swallow capsules or disease significantly affecting gastrointestinal function
• •14. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could have compromised the patient's safety, or put the study at risk
• •15. Required ongoing treatment with medication that are strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers
• •16. History of stroke or intracranial hemorrhage within 6 months prior to enrollment
• •17. Inability to comply with study procedures
• •18. Pregnant or lactating women
• •19. Prior allogenic hematopoietic stem cell transplantation (autologous stem cell transplant is NOT an exclusion)