A Phase Ib/II Study Evaluating the Safety and Efficacy of DA EPOCH in Combination With Mosuntuzumab (EPICSUN) in Previously Untreated C-Myc Rearrangement Positive High-Grade B Cell Lymphomas Including Myc Rearranged Diffuse Large B Cell Lymphoma and High Grade B Cell Lymphoma
OHSU Knight Cancer Institute
Summary
This phase Ib/II clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and/or effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.
Description
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of the mosunetuzumab (M) plus dose-adjusted (DA) etoposide, doxorubicin, vincristine, cyclophosphamide, and prednisone \[EPOCH\] combination in previously untreated c-Myc + diffuse large B cell lymphoma (DLBCL) and high-grade B cell lymphoma. (Phase Ib) II. Evaluate the efficacy of M DA EPOCH as complete response (CR) in previously untreated c-Myc + DLBCL and high grade B cell lymphoma. (Phase II) SECONDARY OBJECTIVES: I. Evaluate the efficacy of M DA EPOCH in Phase Ib and II as overall response, durability of response, and surviva…