A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of Bendamustine + Rituximab With or Without Navitoclax in Patients With Relapsed Diffuse Large B-Cell Lymphoma

Inclusion Criteria:

- Histologically documented diagnosis of diffuse large B-cell lymphoma

- Patients must have relapsed or developed progressive disease following salvage
therapy, or must have relapsed or progressed following initial therapy and in the
opinion of the investigator are medically unfit to receive high dose chemotherapy
with autologous stem cell transplant (SCT) or other salvage therapy of higher
priority

- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- Patients who have undergone STC must be more than 100 days from autologous stem cell
infusion prior to first dose of study drug, must have recovered from any transplant
related toxicity and must have adequate bone marrow function as defined by protocol
independent of any growth factor support

- Patients who have not undergone SCT must have adequate bone marrow function as
defined by protocol independent of any growth factor support

- Adequate coagulation, renal and hepatic function

Exclusion Criteria:

- Refractory DLBCL

- History of other malignancies within 2 years prior to initiation of study treatment
except for adequately treated carcinoma in situ of the cervix, basal or squamous cell
skin carcinoma, low-grade localized prostate cancer treated surgically with curative
intent or one that carries a good prognosis, in situ ductal carcinoma of the breast
treated with lumpectomy (with and without radiation) with curative intent

- Active infection requiring parenteral antibiotics or antiviral or antifungal agents

- Inherited or acquired bleeding diathesis, anticoagulant drugs or drugs that inhibit
platelet function, underlying conditions that predisposes to abnormal bleeding, or
refractoriness to platelet transfusions

- Clinically significant cardiovascular disease, New York Heart Association Grade II or
greater congestive heart failure, or ventricular tachyarrhythmias requiring
medication within 1 year prior to the initiation of study treatment

- Positive for hepatitis B, hepatitis C or HIV infection