Lirilumab (anti-KIR mAb) Combined with Rituximab for Relapsed, Refractory or High-risk Untreated Patients with Chronic Lymphocytic Leukemia (CLL)
The goal of this clinical research study is to learn if lirilumab in combination with rituximab can help to control either CLL or SLL. The safety of the drug combination will also be studied.
Treatment Location: N/A
Primary Objectives 1. To determine the efficacy (response rate) of combined lirilumab and rituximab in patients with high-risk CLL as follows: a. Cohort 1: refractory to and/or relapsed after at least one prior therapy OR b. Cohort 2: untreated patients with high-risk molecular features such as del(17p), mutated TP53, del(11q), unmutated IGHV gene, or are >65 years of age Secondary Objectives 1. To determine the safety of lirilumab combined with rituximab in patients with high-risk CLL. 2. To determine the progression-free survival of patients with high-risk CLL treated with lirilumab combined with rituximab. 3. To determine the overall survival of patients with high-risk CLL treated with lirilumab combined with rituximab. Exploratory Objectives 1. To study immunological and molecular changes in the peripheral blood and bone marrow in response to lirilumab and rituximab therapy.
IRB Review and Approval Date: 06/23/2015
Recruitment Status: Closed
Projected Accrual: N/A
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