A Phase 1b, Multicenter, Open-label, Parallel-group Safety Study of a Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI 32765, in Combination With Chemotherapy in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Inclusion Criteria:

- Histologically confirmed CLL or SLL and satisfying at least 1 of the following
criteria for requiring treatment:

- Progressive splenomegaly and/or lymphadenopathy identified by physical examination or
radiographic studies

- Anemia (<11 g/dL) or thrombocytopenia (<100,000/μL) due to bone marrow involvement

- Presence of unintentional weight loss > 10% over the preceding 6 months

- NCI CTCAE Grade 2 or 3 fatigue

- Fevers > 100.5° or night sweats for > 2 weeks without evidence of infection

- Progressive lymphocytosis with an increase of > 50% over a 2 month period or an
anticipated doubling time of < 6 months

- 1 to 3 prior treatment regimens for CLL/SLL

- ECOG performance status of ≤ 1

≥ 18 years of age

- Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty

- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (in accordance
with national and local subject privacy regulations)

Exclusion Criteria:

- Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or
toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy
within 4 weeks of first dose of study drug Radio- or toxin-conjugated antibody
therapy within 10 weeks of first dose of study drug

- Concomitant use of medicines known to cause QT prolongation or torsades de pointes

- Transformed lymphoma or Richter's transformation Any life-threatening illness,
medical condition or organ system dysfunction which, in the investigator's opinion,
could compromise the subject's safety, interfere with the absorption or metabolism of
PCI-32765 PO, or put the study outcomes at undue risk

- Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) <
1000 cells/mm3 (1.0 x 109/L) oPlatelet count < 50,000/mm3 (50 x 109/L) oSerum
aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper
limit of normal (ULN) oCreatinine > 2.0 x ULN or creatinine clearance < 40 mL/min