A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Exclusion Criteria

• •Known CNS lymphoma or leukemia.
• •No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.
• •Any history of Richter's transformation or prolymphocytic leukemia.
• •Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).
• •Prior exposure to ofatumumab or to ibrutinib.
• •Prior autologous transplant within 6 months prior to first dose of study drug.
• •Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
• •History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
• •Serologic status reflecting active hepatitis B or C infection.
• •Unable to swallow capsules or disease significantly affecting gastrointestinal function.
• •Uncontrolled active systemic fungal, bacterial, viral, or other infection.
• •History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
• •Requires anticoagulation with warfarin.