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

Last updated: January 17, 2025
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT06782789
TALOs
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed diagnosis of R/R DLBCL.

  2. Patientswho received at least one dose of tafasitamab in association withlenalidomide 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

Exclusion Criteria:

  1. R/R DLBCL patients who received tafasitamab in association with lenalidomide in aclinical trial context.

Study Design

Total Participants: 96
Study Start date:
March 01, 2024
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • IRCCS Azienda Ospedaliero - Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • AO Sant'Anna e San Sebastiano di Caserta

    Caserta,
    Italy

    Active - Recruiting

  • A.R.N.A.S. Garibaldi

    Catania,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Arcispedale S. Anna

    Ferrara,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Firenze, 50134
    Italy

    Active - Recruiting

  • Irccs Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Maggiore della Carità

    Novara, 28100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Villa Sofia Cervello

    Palermo, 90146
    Italy

    Active - Recruiting

  • Ospedale Guglielmo da Saliceto di Piacenza

    Piacenza, 29100
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

  • IRCCS- Istituto Nazionale Tumori Regina Elena

    Roma, 00144
    Italy

    Active - Recruiting

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