NCT06782789

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 96 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is pilot, observational, retrospective, Italian multicenter study.

Detailed description

The study will involve the collection of patient data from medical records of patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide as part of standard of care under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022, in several selected Italian centres. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. In fact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.

Conditions

• Diffuse Large B Cell Lymphoma (DLBCL)

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

11 sites across 1 country: Italy