A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

- Diagnosis of mantle cell lymphoma (MCL) reviewed and approved by central
laboratory: diagnosis must include morphology and expression of either cyclin
D1 in association with other relevant markers (eg, CD19, CD20, PAX5) and CD5 or
evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ
hybridization (FISH), or polymerase chain reaction (PCR), - Clinical Stage II,
III, or IV by Ann Arbor Classification, - At least 1 measurable site of disease
according to Revised Response Criteria for Malignant Lymphoma, - No prior
therapies for MCL, - Eastern Cooperative Oncology Group (ECOG) performance
status grade 0 or 1, - Hematology and biochemical laboratory values within
protocol-defined limits, - Agrees to protocol-defined use of effective
contraception, - Negative blood or urine pregnancy test at screening

- Major surgery within 4 weeks of random assignment, - Known central nervous
system lymphoma, - Diagnosed or treated for malignancy other than MCL, except:
malignancy treated with curative intent and with no known active disease
present for >=3 years before random assignment; adequately treated
non-melanoma skin cancer or lentigo maligna without evidence of disease;
adequately treated cervical carcinoma in situ without evidence of disease, -
Patients for whom the goal of therapy is tumor debulking prior to stem cell
transplant, - History of stroke or intracranial hemorrhage within 6 months
prior to random assignment, - Requires anticoagulation with warfarin or
equivalent vitamin K antagonists, - Requires treatment with strong CYP3A
inhibitors, - 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, - Vaccinated with live, attenuated
vaccines within 4 weeks of random assignment, - Known history of human
immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B
virus infection or any uncontrolled active systemic infection requiring
intravenous antibiotics, - Any life-threatening illness, medical condition, or
organ system dysfunction which, in the investigator*s opinion, could compromise
the patient*s safety, interfere with the absorption or metabolism of ibrutinib
capsules, or put the study outcomes at undue risk