Assessing the effectiveness of tafasitamab and lenalidomide in lymphoma 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
This study looks at how well the combination of tafasitamab and lenalidomide works for patients in Italy with relapsed or refractory diffuse large B-cell lymphoma who received this treatment last year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | tafasitamab |
| Locations | 11 sites (Bologna, Bologna and 10 other locations) |
| Trial ID | NCT06782789 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from medical records of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who received tafasitamab in combination with lenalidomide under a named patient program in Italy. The study is retrospective and multicentric, focusing on patients treated between April and December 2022. It aims to evaluate the safety and effectiveness of this treatment combination without any additional interventions beyond standard clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histologically confirmed diagnosis of relapsed/refractory DLBCL who have received tafasitamab and lenalidomide.
Not a fit: Patients who received tafasitamab and lenalidomide as part of a clinical trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of a new treatment combination for patients with DLBCL.
How similar studies have performed: While this approach is observational and retrospective, similar studies have shown promise in evaluating treatment combinations in oncology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed diagnosis of R/R DLBCL. 2. Patientswho received at least one dose of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022. 3. Age ≥ 18 years at enrollment. 4. Signature of written informed consent (if applicable). Exclusion Criteria: 1\) R/R DLBCL patients who received tafasitamab in association with lenalidomide in a clinical trial context.
Where this trial is running
Bologna, Bologna and 10 other locations
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
- AO Sant'Anna e San Sebastiano di Caserta — Caserta, Caserta, Italy (Recruiting)
- A.R.N.A.S. Garibaldi — Catania, Catania, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Arcispedale S. Anna — Ferrara, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Recruiting)
- Irccs Ospedale San Raffaele — Milan, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Maggiore della Carità — Novara, Italy (Recruiting)
- Azienda Ospedaliera Villa Sofia Cervello — Palermo, Italy (Recruiting)
- Ospedale Guglielmo da Saliceto di Piacenza — Piacenza, Italy (Recruiting)
- IRCCS- Istituto Nazionale Tumori Regina Elena — Roma, Italy (Recruiting)
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Pier Luigi Zinzani, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Pier Luigi Zinzani, MD
- Email: pierluigi.zinzani@unibo.it
- Phone: +39 0512144042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.