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

Inclusion Criteria:

   - ECOG performance status of 0-1.

   - Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.

   - Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.

   - Must have received at least one prior therapy for CLL/SLL.

   - Considered not appropriate for treatment or retreatment with purine analog based
   therapy.

   - Measurable nodal disease by CT.

   - Patients must be able to receive outpatient treatment and laboratory monitoring at the
   institution that administers study drug for the entire study.

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.