|Exclusion Criteria:||1) Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of the first dose of study drug.|
2) Prior treatment with ibrutinib or other BTK inhibitors.
3) More than 5 prior lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a > 6 month treatment-free interval).
4) Known central nervous system (CNS) lymphoma.
5) Diagnosed or treated for malignancy other than MCL, except: a. Malignancy treated with curative intent and with no known active disease present for >/= 3 years before the first dose of study drug and felt to be at low risk for recurrence by the treating physician. b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. c. Adequately treated cervical carcinoma in situ without evidence of disease.
6) History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
7) Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon).
8) Requires treatment with strong CYP3A4/5 inhibitors
9) Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
10) Known history of HIV or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
11) Is a woman who is pregnant, or breast-feeding, or planning to become pregnant within 1 month after the last dose of study drug or is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug.
12) Any 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 ibrutinib capsules, or put the study outcomes at undue risk.