Chao Zhou Shi

The trial investigates patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) to evaluate the safety and effectiveness of combining tafasitamab and lenalidomide with gemcitabine and oxaliplatin compared to rituximab combined with gemcitabine and oxaliplatin. This is a randomized, multi-center, Phase 3 study aimed at assessing these treatments in this patient population. The study includes participants who have received one to three prior systemic therapies and are not eligible for high dose therapy or stem cell transplantation. Participants receive either tafasitamab infused intravenously with oral lenalidomide plus intravenous gemcitabine and oxaliplatin, or rituximab infused intravenously with gemcitabine and oxaliplatin. The treatments are administered as per the study protocol to compare the two combinations. The study monitors dose limiting toxicity and other adverse events within 28 days after starting therapy. During the study, participants will be assessed for progression-free survival over approximately one to three years using independent review committee criteria. Researchers will evaluate safety using adverse event reports based on established clinical guidelines. Participants will undergo imaging to measure disease sites, organ function tests, and performance status assessments. Overall, the study monitors treatment safety, disease progression, and patient health over the course of treatment and follow-up.