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



Status:Terminated
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2010
End Date:August 2014

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Trial Summary
Trial Overview
Inclusion Criteria

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.
We found this trial at
1
site
Georgetown University
3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
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