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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborators: Cephalon; GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Bendamustine Hydrochloride; Ofatumumab

Criteria

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.