Actively Recruiting

Age: 18Years +
All Genders
ID06782789

Italian Observational Study on Tafasitamab and Lenalidomide Combination in Patients with Diffuse Large B Cell Lymphoma

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-20

96

Participants Needed

11

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research is a pilot, observational, retrospective study conducted across multiple centers in Italy. It 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 purpose is to assess the effectiveness and safety of this treatment combination as used in real-world clinical practice under the Named Patient Program (NPP). The study collects patient data from medical records of those who received at least one dose of tafasitamab with lenalidomide between April 2022 and December 2022. Since this is a non-interventional study, no additional treatments or procedures are applied beyond what is normally done in clinical care. The treatment details and outcomes reflect standard care settings without extra interventions for the study. Participants will not undergo any procedures outside their usual care. Researchers will gather clinical variables that are typically recorded during routine practice to evaluate outcomes. The main outcome measured is the overall response rate (ORR) to the treatment combination, tracked through study completion, averaging about two years. The study monitors effectiveness and safety by reviewing existing health records without additional patient visits or tests.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of relapsed or refractory Diffuse Large B Cell Lymphoma (DLBCL)
  • Received at least one dose of tafasitamab combined with lenalidomide under the Named Patient Program between April 2022 and December 2022
  • Age 18 years or older at enrollment
  • Signed written informed consent (if applicable)
Not Eligible

You will not qualify if you...

  • Received tafasitamab combined with lenalidomide as part of a clinical trial

AI-Screening

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Trial Site Locations

Total: 11 locations

1

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

2

AO Sant'Anna e San Sebastiano di Caserta

Caserta, Caserta, Italy

Actively Recruiting

3

A.R.N.A.S. Garibaldi

Catania, Catania, Italy

Actively Recruiting

4

Azienda Ospedaliera Universitaria Arcispedale S. Anna

Ferrara, Italy

Actively Recruiting

5

Azienda Ospedaliero Universitaria Careggi

Florence, Italy, 50134

Actively Recruiting

6

Irccs Ospedale San Raffaele

Milan, Italy, 20132

Actively Recruiting

7

Azienda Ospedaliero-Universitaria Maggiore della Carità

Novara, Italy, 28100

Actively Recruiting

8

Azienda Ospedaliera Villa Sofia Cervello

Palermo, Italy, 90146

Actively Recruiting

9

Ospedale Guglielmo da Saliceto di Piacenza

Piacenza, Italy, 29100

Actively Recruiting

10

IRCCS- Istituto Nazionale Tumori Regina Elena

Roma, Italy, 00144

Actively Recruiting

11

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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Research Team

P

Pier Luigi Zinzani, MD

B

Beatrice Casadei, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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