Actively Recruiting
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
Eligibility Criteria
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)
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
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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