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.
The objective of this study is to evaluate efficacy and tolerability of the combination of ofatumumab and lenalidomide in patients with recurrent CLL. The primary end-point will be efficacy and an overall response rate of 40% or higher will be the target for this combination. The secondary endpoint is tolerance of the combination. Excessive toxicity will consist in a rate of grade 3 and 4 non-hematological toxicity in more than 50% of the patients.
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 ]
|Study Start Date:||January 2010|
|Estimated Primary Completion Date:||November 2015 (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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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Alessandra Ferrajoli, MD||UT MD Anderson Cancer Center|