Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin, and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second-Line Treatment of Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse large B-cell lymphoma (DLBCL) is a form of non-Hodgkin lymphoma that affects B lymphocytes, a subtype of white blood cells that are part of the body’s immune system. In DLBCL, rapid enlargement of the lymph nodes and spread to other organs may occur. Other symptoms include fever, night sweats, and weight loss, among others. The exact cause of DLBCL is unknown, but genetic mutations and infections such as the Epstein-Barr virus may play a role. Patients with newly diagnosed DLBCL are typically treated with a combination of chemotherapy and immunotherapy, such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). If the disease returns (relapse) after this treatment or if it cannot be controlled (refractory), alternative treatment options are needed, such as the R-ICE regimen (drugs: rituximab, ifosfamide, carboplatin, and etoposide), which also combines chemotherapy and immunotherapy.

The aim of this Phase 3 study is to investigate the efficacy and safety of polatuzumab vedotin in addition to R-ICE in a larger number of patients. Patients will be randomly assigned to 2 groups. Group 1 will receive the conventional R-ICE regimen. Group 2 will receive the combination of polatuzumab vedotin and R-ICE. Polatuzumab vedotin is a drug in the immunotherapy class (antibodies) that is already approved for the treatment of DLBCL. However, the combination with R-ICE has not yet been tested and is therefore not approved. The treatment consists of 3 cycles of 21 days each. Polatuzumab vedotin and rituximab are each administered on the first day of a cycle; ifosfamide and carboplatin on day 2 of a cycle; and etoposide on days 1, 2, and 3 of a cycle. The study is open-label, meaning that both the medical staff and the patient know which medications are being administered. Treatment and follow-up as part of the study will continue for up to 24 months, during which the efficacy of the therapy and the occurrence of side effects from the various medications will be evaluated. The key factor is whether or when the disease progresses again during treatment. The primary endpoint of the study is event-free survival at 24 months.

Patients aged 18 and older with DLBCL are eligible to participate in this study. The disease must either be uncontrollable (refractory) or have recurred.