Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia

The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.

Inclusion Criteria:

• Pathologically confirmed CLL or SLL requiring therapy
• Age 18 years of age or older
• ECOG performance status 0, 1, or 2
• Normal organ and bone marrow function
• Resolution of toxic effects from prior therapies
• Ability to adhere to the study schedule and give written informed consent

Exclusion Criteria:

• Any serious medical, psychiatric illness or laboratory abnormality
• Chemotherapy or radiotherapy within 4 weeks of entering the study
• Currently receiving other treatment for CLL/SLL or other malignancies
• Active other malignancies
• History of allergic reactions to bendamustine or ofatumumab
• Ongoing corticosteroid use
• Pregnant or lactating
• HIV positive
• Active hepatitis B
• Allogeneic transplant within 6 months of entering study or graft-versus-host disease.