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
- 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
- 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.
- 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
- Prior exposure to ofatumumab or to ibrutinib.
- Prior autologous/allogeneic transplant
- 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
- 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.