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A Phase 1/2 Open-Label Multicenter Study of CC-122 in Combination with R-CHOP-21 for Previously Untreated Poor-Risk (IPI>/= 3) Diffuse Large B-Cell Lymphoma
This is Phase 1/2 study of CC-122 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, for first-line treatment of patients with Diffuse B-Cell Large B-Cell Lymphoma (DLBCL) that has poor risk factors. Approximately 40% of patients diagnosed with DLBCL are not cured with R-CHOP alone and would need additional treatment for DLBCL in the future. The addition of the experimental drug CC-122 with R-CHOP could help in controlling DLBCL in this patient population.
Primary Objectives: The primary objective of the Phase 1 portion of the study is to evaluate the safety and tolerability of CC-122 in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy and the anti-CD20 monoclonal antibody rituximab (R-CHOP) given in 21-day treatment cycles (R-CHOP-21) for first-line treatment of patients with poor-risk (IPI >/= 3) DLBCL in order to identify an appropriate dose and schedule for further investigation in Phase 2. The primary objective of the Phase 2 portion of the study is to evaluate the rate of complete response (CR) when adding CC-122 to the standard R-CHOP-21 regimen in first-line treatment of patients with poor-risk DLBCL. Secondary Objectives: Phase 1: To evaluate early signals of efficacy. Phase 2: To characterize additional efficacy parameters such as progression-free survival (PFS) and overall survival (OS). To further describe the safety and tolerability associated with CC-122 in combination with R-CHOP-21 in this setting. To evaluate biomarkers which are predictive of clinical response to CC-122, when administered in combination with R-CHOP-21.