Phase II Study of Glofitamab Plus Polatuzumab with R-CHP Chemotherapy for High-Risk Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the combination of study drugs Glofitamab and Polatuzumab with a standard chemotherapy regimen called R-CHP as a treatment for patients with high-risk diffuse large B-cell lymphoma DLBCL. This phase II clinical trial focuses on patients who have not received prior treatment for this type of lymphoma. The study aims to assess how well these drugs work together and to understand their safety profile in this patient population. Participants in this open-label, single-arm study will receive treatment over up to 8 cycles. Initially, they will get two cycles of Polatuzumab combined with R-CHP chemotherapy, followed by four cycles of Glofitamab with Polatuzumab and R-CHP. After completing chemotherapy, participants will receive two additional cycles of Glofitamab alone. The drugs are administered mainly through intravenous infusions, with Prednisone taken orally. Participants who need urgent therapy may receive one cycle of R-CHOP chemotherapy. Following treatment, patients will be monitored for up to 5 years. During the study, participants will undergo screening evaluations, tumor scans, tumor biopsies, heart function tests, and blood draws. Researchers will monitor treatment effects by measuring the rate of complete response 28 days after the final treatment cycle, as well as other outcomes such as treatment toxicities, overall response, and progression-free survival over time. The study will also track changes in tumor DNA levels. Participants health will be followed for several years to collect long-term data on treatment outcomes and safety.

A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma