Odronextamab (a new drug) in combination with chemotherapy for the treatment of previously untreated 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. 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). However, new drugs are constantly being investigated that are designed to target cancer cells more specifically in order to kill them more effectively while causing fewer side effects. Odronextamab is a novel antibody that attacks cancer cells while simultaneously stimulating the body’s own immune system (bispecific). It is already approved for the treatment of other lymphomas, as well as for DLBCL with recurrent disease activity or a treatment-resistant form.

The goal of this Phase 3 study is to investigate the efficacy and safety of odronextamab in combination with chemotherapy in a larger number of patients. In the first phase of the study, the safety of odronextamab in combination with the CHOP chemotherapy regimen (cyclophosphamide, doxorubicin, vincristine, prednisone) in terms of tolerability and the occurrence of side effects, and the optimal dose for follow-up therapy will be determined. In addition, participants will be randomly assigned to two groups. Group 1 will receive odronextamab in combination with CHOP, and Group 2 will receive the standard therapy with R-CHOP (rituximab + CHOP). The study is open-label, meaning that both the medical staff and the patient know which medications are being administered. Treatment as part of the study lasts for up to 60 months, during which the efficacy of the therapy and the occurrence of side effects from the various medications are evaluated. The key factor is whether or when the disease progresses again during therapy. The primary endpoint of the second phase of the study is the 5-year progression-free survival rate.

Patients aged 18 and older with DLBCL who have not previously received treatment are eligible to participate in this study.