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

NCT ID: NCT06782789

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-08-31

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pier Luigi Zinzani, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

AO Sant'Anna e San Sebastiano di Caserta

Caserta, Caserta, Italy

Site Status: RECRUITING

A.R.N.A.S. Garibaldi

Catania, Catania, Italy

Site Status: RECRUITING

Azienda Ospedaliera Universitaria Arcispedale S. Anna

Ferrara, , Italy

Site Status: RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Site Status: RECRUITING

Irccs Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Azienda Ospedaliero-Universitaria Maggiore della Carità

Novara, , Italy

Site Status: RECRUITING

Azienda Ospedaliera Villa Sofia Cervello

Palermo, , Italy

Site Status: RECRUITING

Ospedale Guglielmo da Saliceto di Piacenza

Piacenza, , Italy

Site Status: RECRUITING

IRCCS- Istituto Nazionale Tumori Regina Elena

Roma, , Italy

Site Status: RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Pier Luigi Zinzani, MD

Role: CONTACT

pierluigi.zinzani@unibo.it

+39 0512144042

Beatrice Casadei, MD

Role: CONTACT

beatrice.casadei@aosp.bo.it

+39 0512143680

Facility Contacts

Pier Luigi Zinzani, MD

Role: primary

pierluigi.zinzani@unibo.it

+390512144042

Giusy Cetani, MD

Role: primary

giusy.cetani@aorncaserta.it

+39 0823 232935

Giusy Cetani, MD

Role: backup

Ugo Consoli, MD

Role: primary

ugo.consoli144@gmail.com

+39 0957595801

Ugo Consoli, MD

Role: backup

Giulia Daghia, MD

Role: primary

giulia.daghia@ospfe.it

+39 0532 236978

Maria Rosariaa Sessa, MD

Role: backup

m.sessa@ospfe.it

+390532236992

Giulia Daghia, MD

Role: backup

Luca Nassi, MD

Role: primary

nassil@aou-car.it

+39 055 947358

Benedetta Sordi, MD

Role: backup

benedetta.sordi@unifi.it

+39 055 7947358

Luca Nassi, MD

Role: backup

Andrés José Maria Ferreri, MD

Role: primary

ferreri.clinicaltrials@hsr.it

+39 02 2643 4289

Piera Angelillo, MD

Role: backup

angelillo.piera@hsr.it

+39 02 2643 3903

Andrés José Maria Ferreri, MD

Role: backup

Riccardo Bruna, MD

Role: primary

riccardo.bruna@med.uniupo.it

+39 03213733127

Giulia Maria Rivolta, MD

Role: backup

20042325@studenti.uniupo.it

+39 0321373312

Riccardo Bruna, MD

Role: backup

Caterina Patti, MD

Role: primary

K.patti@villasofia.it

+39 0916802037

Vittoria Tarantino, MD

Role: backup

vittoriatarantino@hotmail.it

+39 0916802773

Caterina Patti, MD

Role: backup

Patrizia Bernuzzi, MD

Role: primary

p.bernuzzi@ausl.pc.it

+39 0523303719

Annalisa Arcari, MD

Role: backup

a.arcari@ausl.pc.it

+39 0523303719

Patrizia Bernuzzi, MD

Role: backup

Francesca Palombi, MD

Role: primary

francesca.palombi@ifo.it

+39 0652665529

Daniela Renzi, MD

Role: backup

daniela.renzi@ifo.it

+39 0652662847

Francesca Palombi, MD

Role: backup

Francesco D'Alò, MD

Role: primary

francesco.dalo@policlinicogemelli.it

+39 3497884529

Flaminia Bellissario, MD

Role: backup

flaminia.bellissario@gmail.com

+39 3391455175

Francesco D'Alò, MD

Role: backup

Other Identifiers

TALOs

Identifier Type: -

Identifier Source: org_study_id