Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Exclusion Criteria

• •1. Current or history of central nervous system (CNS) lymphoma
• •2. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor
• •3. Prior corticosteroids given in excess of prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days.
• •4. Major surgery within 4 weeks of screening
• •5. Not recovered from toxicity of any prior anti-cancer therapy to \<Grade 1 (except for alopecia, absolute neutrophil count (ANC) and platelets.
• •6. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent
• •7. Currently active clinically significant cardiovascular disease
• •8. QTcF \>480 msecs based on Fridericia's formula or other significant electrocardiogram abnormalities including second degree atrioventricular (AV) block Type II, or third degree AV block
• •9. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
• •10. Active infection including infections requiring oral or intravenous anti-microbials
• •11. Known human immunodeficiency virus (HIV), or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction \[PCR\]).
• •12. Has received allogenic hematopoietic stem cell transplantation prior to enrollment
• •13. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participants's safety, or put the study at risk
• •14. Requires ongoing treatment with any medication which is a strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitor or strong CYP3A inducer
• •15. Known or clinically suspected Richter's transformation at the time of study entry
• •16. History of stroke or intracranial hemorrhage within 6 months prior to enrollment