Study of BTK Inhibitor Zanubrutinib in Participants With Relapsed/Refractory Non-GCB Type Diffuse Large B Cell Lymphoma

Inclusion Criteria

• •1. Histologically confirmed non-germinal center DLBCL, by immunohistochemistry using the Hans algorithm:
• •1. Cluster of differentiation 10 (CD10)- and B-cell lymphoma 6 protein (BCL6)-,
• •2. CD10-, BCL6+, but maximal unique match+
• •2. Men and women ≥ 18 years of age.
• •3. Eastern Cooperative Oncology Group performance status of 0-2.
• •4. Measurable disease was defined as at least 1 lymph node \> 1.5 centimeters in longest diameter and measurable in 2 perpendicular dimensions.
• •5. All participants must have provided fresh tumor biopsy or recent tumor tissue samples (within 2 years of study entry \[informed consent form signed\]).
• •6. Received at least one prior therapy for DLBCL that included anthracycline-based chemotherapy.
• •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 such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or history of myocardial infarction within 6 months of screening. Left ventricular ejection fraction is lower than 50% measured by echocardiography.
• •8. QTcF (Fridericia's correction) \> 450 milliseconds 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. Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
• •11. Known human immunodeficiency virus, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction).
• •12. Pregnant or lactating women.
• •13. Any life-threatening illness, medical condition or organ system dysfunction, which, in the investigator's opinion, could compromise the participant's safety, or put the study at risk.
• •14. On medications that were strong cytochrome P450 (CYP), family 3, subfamily A (CYP3A) inhibitors or CYP3A inducers.