| Exclusion Criteria: | 1) A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral PCI-32765, or put the study outcomes at undue risk.
2) Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
3) Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
4) Concomitant immunotherapy, chemotherapy, radiotherapy, corticosteroids (at doses equivalent to prednisone >20 mg/day), or experimental therapy that was not indicated or permitted in the parent study.
5) Central nervous system involvement by lymphoma.
6) Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
7) Creatinine >1.5 x institutional upper limit of normal (ULN); total bilirubin >1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or ALT >2.5 x ULN unless disease related.
8) Lactating or pregnant.
9) 1) Those patients with CLL/SLL not previously treated on Protocol 2010-0314 or 2011-0142. |