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

Stopped early · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT01010568

Run by

Georgetown University

People needed

10

Starts

2010-04-01

Expected to finish

2014-08-01

Last updated by the study team

2015-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Georgetown University — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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