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

Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's
Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with
Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

Patients randomized to the ofatumumab arm may be considered to receive next subsequent
therapy with ibrutinib.

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.