Lenalidomide and Ofatumumab in Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)
The goal of this clinical research study is to learn if the combination of lenalidomide and ofatumumab can help to control CLL or SLL in patients who have already received therapy. The safety of this drug combination will also be studied.
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Combination of Lenalidomide and Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)|
- Overall Response [ Time Frame: Responses assessed after 3, 6, 12, 18 and 24 cycles (each cycle is 28 days) and every 6-12 months as clinically indicated. ] [ Designated as safety issue: No ]Overall response includes complete remission (CR) and partial remission (PR). Patients are considered non-responders if there is progression of disease.
|Study Start Date:||January 2010|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide + Ofatumumab
Lenalidomide 10 mg daily up to 24 cycles (cycle = 28 day); Ofatumumab IV infusions 300 mg week 1; 1,000 mg week 2, 3 and 4, then monthly during months 2-6 and once every two months during months 7-24.
10 mg daily, started on day 9 (day after second infusion of ofatumumab) and continued daily through 24 cycles (cycle = 28 day)
Other Names:Drug: Ofatumumab
4 weekly IV infusions of 300 mg week 1, 1,000 mg week 2, 3 and 4, then monthly during months 2-6 and once every two months during months 7-24 (even months: 8,10,12 etc.).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01002755
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Alessandra Ferrajoli, MD||M.D. Anderson Cancer Center|