Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia

This Phase 1/1b open-label study consists of two parts. The initial dose escalation stage is
a Phase 1b study evaluating the safety and tolerability of two doses of TRU-016 administered
in combination with bendamustine to patients with relapsed chronic lymphocytic leukemia
(CLL). In the randomized Phase 2 stage of the study, the efficacy and safety of the selected
dose of TRU-016 from the first stage of the study combined with bendamustine will be
compared to bendamustine alone. The pharmacokinetics and pharmacodynamics of TRU-016 and the
development of antibodies to TRU-016 will be evaluated in both phases of the study.

Inclusion Criteria:

- Diagnosis of relapsed CLL with 1 to 3 prior treatments

- Demonstrated active disease requiring treatment

- No prior bendamustine treatment

- Not refractory to fludarabine or other purines, either as a single agent or in
combination

- Age >/=18 years; male or female

- ECOG performance status of
- Creatinine clearance > 40 mL/min

- ANC >/= 1,200/mm3

- Platelets >/= 75,000/mm3

- Lymphocytes >/= 5,000/mm3 in Phase 1b

Exclusion Criteria:

- Treatment with rituximab or other B-cell depleting agent within 30 days or
alemtuzumab within 12 weeks

- Previous anticancer therapy within 30 days

- Refractory to prior fludarabine or other purine analog therapy either as a single
agent or in combination

- Receipt of prior bendamustine or TRU-016

- Receipt of an investigational therapy or major surgery within 30 days

- Previous or concurrent additional malignancy (some exceptions apply)

- Any significant concurrent medical diseases or conditions

- Positive serology for HIV or hepatitis C, hepatitis B surface antigen positive or
hepatitis B core antibody positive.

- Pregnant or breast feeding

- Drug or alcohol abuse

- Allergic to mannitol