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)

January 17, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Carità
    - 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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:

Histologically confirmed diagnosis of R/R DLBCL.
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.
Age ≥ 18 years at enrollment.
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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate (ORR) Time Frame: through study completion, an average of 2 years	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) Time Frame: through study completion, an average of 2 years	Best response rate (BRR)	through study completion, an average of 2 years
Duration of Response (DoR) Time Frame: through study completion, an average of 2 years	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 Time Frame: from enrollment untill 30 days from last infusion	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) Time Frame: through study completion, an average of 2 years	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) Time Frame: through study completion, an average of 2 years	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) Time Frame: through study completion, an average of 2 years	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

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)