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 (TALOs)

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

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B Cell Lymphoma (DLBCL)

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.

• Study Type: Observational
• Enrollment (Estimated): 96

Contacts and Locations

• Study Contact: Name: Beatrice Casadei, MD; Phone Number: +39 0512143680; Email: beatrice.casadei@aosp.bo.it
• Study Contact Backup: Name: Pier Luigi Zinzani, MD; Phone Number: +39 0512144042; Email: pierluigi.zinzani@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    • Contact: Pier Luigi Zinzani, MD; Phone Number: +390512144042; Email: pierluigi.zinzani@unibo.it
  • Caserta, Italy
    • Recruiting
    • AO Sant'Anna e San Sebastiano di Caserta
    • Contact: Giusy Cetani, MD
    • Contact: Giusy Cetani, MD; Phone Number: +39 0823 232935; Email: giusy.cetani@aorncaserta.it
  • Catania, Italy
    • Recruiting
    • A.R.N.A.S. Garibaldi
    • Contact: Ugo Consoli, MD
    • Contact: Ugo Consoli, MD; Phone Number: +39 0957595801; Email: ugo.consoli144@gmail.com
  • Ferrara, Italy
    • Recruiting
    • Azienda Ospedaliera Universitaria Arcispedale S. Anna
    • Contact: Giulia Daghia, MD; Phone Number: +39 0532 236978; Email: giulia.daghia@ospfe.it
    • Contact: Maria Rosariaa Sessa, MD; Phone Number: +390532236992; Email: m.sessa@ospfe.it
    • Contact: Giulia Daghia, MD
  • Firenze, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero Universitaria Careggi
    • Contact: Luca Nassi, MD
    • Contact: Luca Nassi, MD; Phone Number: +39 055 947358; Email: nassil@aou-car.it
    • Contact: Benedetta Sordi, MD; Phone Number: +39 055 7947358; Email: benedetta.sordi@unifi.it
  • Milano, Italy, 20132
    • Recruiting
    • IRCCS Ospedale San Raffaele
    • Contact: Andrés José Maria Ferreri, MD; Phone Number: +39 02 2643 4289; Email: ferreri.clinicaltrials@hsr.it
    • Contact: Piera Angelillo, MD; Phone Number: +39 02 2643 3903; Email: angelillo.piera@hsr.it
    • Contact: Andrés José Maria Ferreri, MD
  • Novara, Italy, 28100
    • Recruiting
    • Azienda Ospedaliero-Universitaria Maggiore Della Carita
    • Contact: Riccardo Bruna, MD
    • Contact: Riccardo Bruna, MD; Phone Number: +39 03213733127; Email: riccardo.bruna@med.uniupo.it
    • Contact: Giulia Maria Rivolta, MD; Phone Number: +39 0321373312; Email: 20042325@studenti.uniupo.it
  • Palermo, Italy, 90146
    • Recruiting
    • Azienda Ospedaliera Villa Sofia Cervello
    • Contact: Caterina Patti, MD
    • Contact: Caterina Patti, MD; Phone Number: +39 0916802037; Email: K.patti@villasofia.it
    • Contact: Vittoria Tarantino, MD; Phone Number: +39 0916802773; Email: vittoriatarantino@hotmail.it
  • Piacenza, Italy, 29100
    • Recruiting
    • Ospedale Guglielmo da Saliceto di Piacenza
    • Contact: Patrizia Bernuzzi, MD; Phone Number: +39 0523303719; Email: p.bernuzzi@ausl.pc.it
    • Contact: Annalisa Arcari, MD; Phone Number: +39 0523303719; Email: a.arcari@ausl.pc.it
    • Contact: Patrizia Bernuzzi, MD
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Francesco D'Alò, MD; Phone Number: +39 3497884529; Email: francesco.dalo@policlinicogemelli.it
    • Contact: Flaminia Bellissario, MD; Phone Number: +39 3391455175; Email: flaminia.bellissario@gmail.com
    • Contact: Francesco D'Alò, MD
  • Roma, Italy, 00144
    • Recruiting
    • IRCCS- Istituto Nazionale Tumori Regina Elena
    • Contact: Francesca Palombi, MD; Phone Number: +39 0652665529; Email: francesca.palombi@ifo.it
    • Contact: Daniela Renzi, MD; Phone Number: +39 0652662847; Email: daniela.renzi@ifo.it
    • Contact: Francesca Palombi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with R/R DLBCL who have received 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate (ORR)	ORR as the sum of complete response [CR] and partial response [PR] rate. The study aims to retrospectively evaluate the effectiveness of tafasitamab in association with lenalidomide in patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide under the NPP.	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best response rate (BRR)	Best response rate (BRR)	through study completion, an average of 2 years
Duration of Response (DoR)	the secondary aim is to evaluate effectiveness of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017)	through study completion, an average of 2 years
Toxicity of study drug	Type, incidence, severity of any adverse events (AE) occurred from start of treatment to 30 days after last infusion and their possible relationship with study drugs	from enrollment untill 30 days from last infusion
Progression Free Survival (PFS)	The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.	through study completion, an average of 2 years
Overall Survival (OS)	Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause.	through study completion, an average of 2 years
Duration Free Survival (DFS)	Disease free survival (DFS) is defined as the time from randomization until evidence of disease recurrence	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: lenalidomide; tafasitamab
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: TALOs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No