Ofatumumab Early Treatment for High-Risk Treatment-Naive, Early Stage (0-II) Patients with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
The goal of this clinical research study is to learn if ofatumumab can help to control CLL/SLL that has not yet been treated. The safety of this drug will also be studied.
Treatment Location: N/A
1. The primary objective is to determine the response rate (IWCLL/NCI-WG criteria) to treatment with single-agent ofatumumab in previously untreated, early stage, high-risk patients with CLL/SLL The secondary objectives are: 1. Determine time-to-progression in high-risk patients treated with ofatumumab. 2. Determine time-to-next chemotherapy or alternative therapy. 3. Evaluate the pharmacokinetics of single-agent ofatumumab in high-risk, previously treated patients with CLL.4. Evaluate for circulating CD20+ cells through treatment and in follow-up in high-risk patients treated with ofatumumab. 5. Evaluate safety and toxicities of ofatumumab in previously untreated high-risk patients with CLL/SLL.
IRB Review and Approval Date: 03/22/2011
Recruitment Status: Closed
Projected Accrual: N/A