A Phase 1b Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria:

- Diagnosis of CLL by 2008 IWCLL criteria and with Rai stage intermediate or high risk
CLL

- No prior therapy for CLL for Cohorts 1 and 3. For Cohort 2, 1-3 prior treatments.

- At least one of the following criteria for active disease requiring treatment:
progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to
bone marrow involvement; or progressive lymphocytosis with an increase of >50% over a
2-month period or an unanticipated doubling time of less than 6 months

- Contraindication to chemotherapy as first-line therapy due to patient age,
comorbidity or patient preference

- Age >/= to 18 years

- ECOG performance status of
- Life expectancy > 6 months in opinion of Investigator

- Serum creatinine, total bilirubin, ALT/SGPT
- ANC >/= 800/mm3

- Platelets >/= 30,000/mm3

Exclusion Criteria:

- For Cohorts 1 and 3 only: Has received treatment with rituximab, alemtuzumab,
ofatumumab or any other chemotherapeutic agent for CLL

- Has received an investigational therapy within 30 days of first dose of study drug

- Previous or concurrent additional malignancy

- Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone
marrow transplant, active autoimmune disease

- Positive serology for HIV or hepatitis C

- Hepatitis B surface antigen or hepatitis B core antibody positive

- Pregnant or breastfeeding

- Known current drug or alcohol abuse