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

Recruiting

• Conditions: Diffuse Large B Cell Lymphoma (DLBCL)

• Registration Number: NCT06782789
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall response rate (ORR)	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	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)
Toxicity of study drug	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
Progression Free Survival (PFS)	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.
Overall Survival (OS)	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.
Duration Free Survival (DFS)	through study completion, an average of 2 years	Disease free survival (DFS) is defined as the time from randomization until evidence of disease recurrence
Best response rate (BRR)	through study completion, an average of 2 years	Best response rate (BRR)

Trial Locations

Locations (11)

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy

AO Sant'Anna e San Sebastiano di Caserta; 🇮🇹 Caserta, Italy

A.R.N.A.S. Garibaldi; 🇮🇹 Catania, Italy

Azienda Ospedaliera Universitaria Arcispedale S. Anna; 🇮🇹 Ferrara, Italy

Ospedale Guglielmo da Saliceto di Piacenza; 🇮🇹 Piacenza, Italy

IRCCS- Istituto Nazionale Tumori Regina Elena; 🇮🇹 Roma, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

Irccs Ospedale San Raffaele; 🇮🇹 Milano, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità; 🇮🇹 Novara, Italy

Azienda Ospedaliera Villa Sofia Cervello; 🇮🇹 Palermo, Italy