Fatigue Clinical Trial
Official title:
Combination of Lenalidomide and Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)
This phase II trial studies how well lenalidomide and ofatumumab work in treating participants with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and ofatumumab may work better in treating participants with chronic lymphocytic leukemia or small lymphocytic lymphoma
PRIMARY OBJECTIVES:
I. To evaluate efficacy and tolerability of the combination of ofatumumab and lenalidomide in
patients with recurrent chronic lymphocytic leukemia (CLL).
OUTLINE:
Participants receive ofatumumab intravenously (IV) over 4 hours on days 1, 8, 15, and 22 of
course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning
day 9 of course 1, participants also receive lenalidomide orally (PO) daily. Courses repeat
every 28 days for up to 2 years in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, participants are followed up at 6 months, then every 3
months thereafter.
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