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

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
Eastern Cooperative Oncology Group (ECOG) performance status of Creatinine clearance > 40 mL/min
Absolute neutrophil count (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