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

NCT06782789 | Recruiting

• 1 other identifier: TALOs
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Keywords

tafasitamab; lenalidomide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of Response (DoR)

  through study completion, an average of 2 years

• Toxicity of study drug

  from enrollment untill 30 days from last infusion

• Progression Free Survival (PFS)

  through study completion, an average of 2 years

• Overall Survival (OS)

  through study completion, an average of 2 years

• Duration Free Survival (DFS)

  through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• \) R/R DLBCL patients who received tafasitamab in association with lenalidomide in a clinical trial context.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (11)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, 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, 50134, Italy

RECRUITING

Irccs Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Azienda Ospedaliera Villa Sofia Cervello

Palermo, 90146, Italy

RECRUITING

Ospedale Guglielmo da Saliceto di Piacenza

Piacenza, 29100, Italy

RECRUITING

IRCCS- Istituto Nazionale Tumori Regina Elena

Roma, 00144, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+39 0512144042; pierluigi.zinzani@unibo.it

Beatrice Casadei, MD

CONTACT

+39 0512143680; beatrice.casadei@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 20, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (11)