Italian Multicenter Retrospective Study on the Safety and Effectiveness of Tafasitamab and Lenalidomide Combination in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

This observational study focuses on patients with relapsed or refractory Diffuse Large B Cell Lymphoma DLBCL who have been treated with a combination of tafasitamab and lenalidomide. The study aims to assess the effectiveness and safety of this combination in a real-world setting using data collected retrospectively from medical records. It is a pilot, multicenter study conducted in Italy, observing clinical practice without introducing new treatments or interventions. The study gathers data from patients treated between April 2022 and December 2022 under a Named Patient Program. Since this is a retrospective study, it does not involve administering therapies or altering patient care. Instead, it collects clinical variables that physicians routinely record during standard treatment, focusing on patients who received at least one dose of the combined drugs. Participants involvement consists of allowing researchers to review their medical records for data on treatment response, survival rates, and any toxicities experienced. The main outcome measured is the overall response rate, observed over an average of two years, alongside other outcomes such as duration of response, progression-free survival, and overall survival. Safety data is collected from enrollment until 30 days after the last infusion, with no additional procedures required from patients.

An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program