Phase 3 Study Comparing Tafasitamab and Lenalidomide with Gemcitabine and Oxaliplatin Versus Rituximab with Gemcitabine and Oxaliplatin in Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating treatments for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma DLBCL, a type of lymphoma that has returned or does not respond to previous therapy. This randomized, multi-center Phase 3 study compares the safety and effectiveness of combining Tafasitamab and Lenalidomide with Gemcitabine and Oxaliplatin against Rituximab combined with Gemcitabine and Oxaliplatin. The study aims to better understand the dose-limiting toxicities and progression-free survival in this patient group. The study involves two treatment groups. One group receives Tafasitamab through intravenous infusion and Lenalidomide orally, together with Gemcitabine and Oxaliplatin given intravenously. The other group receives Rituximab infused intravenously along with Gemcitabine and Oxaliplatin. Treatments are administered according to a schedule designed to assess safety and effectiveness. The study includes approximately 1 to 3 years of follow-up to evaluate the duration of response and overall survival among participants. Participants will undergo assessments including imaging scans to measure disease sites, laboratory tests to monitor organ function, and evaluations for adverse events using standard criteria. Quality of life is assessed through patient-reported questionnaires on happiness and general health. The study tracks multiple outcomes such as response rates, progression-free survival, and time to next treatment. Participation lasts several years, including ongoing safety monitoring and quality of life assessments throughout the study period.

Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma