Safety and Tolerability Study of Polatuzumab Vedotin with Dose-Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin, With or Without Glofitamab, for Initial Treatment of Aggressive Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the side effects and safety of polatuzumab vedotin combined with chemotherapy, with or without glofitamab, for patients with untreated aggressive large B-cell lymphoma. This phase I trial focuses on lymphomas that grow and spread quickly and cause severe symptoms, aiming to understand how these treatments work together and their tolerability. Polatuzumab vedotin targets cancer cells by delivering a toxic agent directly to them, while glofitamab may block cancer cell growth. Other drugs in the chemotherapy mix work by stopping cancer cell growth and spread in different ways. Participants are assigned to one of two treatment groups. One group receives rituximab, polatuzumab vedotin, prednisone, etoposide, doxorubicin, cyclophosphamide, and filgrastim in repeated cycles every 21 days for up to six cycles. The other group receives the same treatment plus glofitamab starting from the second cycle. Treatments involve intravenous infusions and oral medication. Throughout the study, patients undergo scans including MUGA or echocardiography, FDG PET, CT scans, bone marrow biopsy and aspiration, and blood sample collection. After treatment, patients are followed for up to five years to monitor health. During the trial, participants will have regular imaging and laboratory tests to assess their response and monitor safety. Researchers focus on tracking side effects up to 30 days after treatment and how many patients can complete the full six cycles without stopping due to reasons other than disease progression. Participants heart function, blood counts, and organ health are also carefully checked. The trial involves careful monitoring to understand how well patients tolerate the treatments and to gather data for future care options.

Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma