A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma

Inclusion Criteria: * Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or pathological evidence of transformation * Previously treated with at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen; last prior line of therapy includes an anti CD20 monoclonal antibody-containing chemotherapy regimen (separate lines of therapy are defined as different regimens that are either separated by disease progression, refractory disease, or relapsed disease) * Resistant disease to the last therapy, defined as progression of disease during or within 12 months of the last dose of chemotherapy in a CD20 antibody combination chemotherapy regimen * At least 1 measurable site of disease according to International Working Group Revised Response Criteria for Malignant Lymphoma * Eastern Cooperative Oncology Group performance status grade 0 or 1 * Hematology and biochemical laboratory values must be within protocol-defined parameters within 7 days prior to enrollment * Agrees to protocol-defined use of effective contraception * Women of childbearing potential must have a negative serum or urine pregnancy test at screening Exclusion Criteria: * Prior nitrosoureas within 6 weeks, chemotherapy within 3 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 first dose of study drug * Prior treatment with PCI-32765 or other Bruton's tyrosine kinase inhibitors (patients who progressed or became refractory while on treatment with PI3K inhibitors are excluded) * Concurrent enrollment in another therapeutic investigational clinical treatment study * Received a prior allogeneic hematopoietic stem cell transplant (prior autologous hematopoietic stem cell transplant is allowed) * Known central nervous system lymphoma * History of prior malignancy (except malignancy treated with curative intent and with no known active disease present for \>=3 years before enrollment, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated cervical carcinoma in situ without evidence of disease) * History of stroke or intracranial hemorrhage within 6 months prior to enrollment * Requires anticoagulation with warfarin or equivalent vitamin K antagonists * Requires treatment with strong cytochrome P450 (CYP)3A4/5 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 * Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C or active infection with Hepatitis B or any uncontrolled active systemic infection requiring intravenous antibiotics * Women who are pregnant or breastfeeding * 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 PCI-32765 capsules, or put the study outcomes at undue risk