Clinical trial NCT06782789: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diffuse Large B Cell Lymphoma (DLBCL)
Keywords: tafasitamab
lenalidomide
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall response rate (ORR)
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: through study completion, an average of 2 years
measure: Toxicity of study drug
timeFrame: from enrollment untill 30 days from last infusion
measure: Progression Free Survival (PFS)
timeFrame: through study completion, an average of 2 years
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 years
measure: Duration Free Survival (DFS)
timeFrame: through study completion, an average of 2 years
measure: Best response rate (BRR)
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
city: Caserta
country: Italy
facility: AO Sant'Anna e San Sebastiano di Caserta
city: Catania
country: Italy
facility: A.R.N.A.S. Garibaldi
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedale S. Anna
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria Maggiore della Carità
city: Palermo
country: Italy
facility: Azienda Ospedaliera Villa Sofia Cervello
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto di Piacenza
city: Roma
country: Italy
facility: IRCCS- Istituto Nazionale Tumori Regina Elena
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: