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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diffuse Large B Cell Lymphoma (DLBCL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- overall response rate (ORR) [Time frame: through study completion, an average of 2 years]
Secondary outcome measures (6)
- Duration of Response (DoR) [Time frame: through study completion, an average of 2 years]
- Toxicity of study drug [Time frame: from enrollment untill 30 days from last infusion]
- Progression Free Survival (PFS) [Time frame: through study completion, an average of 2 years]
- Overall Survival (OS) [Time frame: through study completion, an average of 2 years]
- Duration Free Survival (DFS) [Time frame: through study completion, an average of 2 years]
- Best response rate (BRR) [Time frame: through study completion, an average of 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 11 centers
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna
- AO Sant'Anna e San Sebastiano di Caserta — Caserta
- A.R.N.A.S. Garibaldi — Catania
- Azienda Ospedaliera Universitaria Arcispedale S. Anna — Ferrara
- Azienda Ospedaliero Universitaria Careggi — Florence
- Irccs Ospedale San Raffaele — Milan
- Azienda Ospedaliero-Universitaria Maggiore della Carità — Novara
- Azienda Ospedaliera Villa Sofia Cervello — Palermo
- … and 3 more centers
Identifiers
NCT: NCT06782789 · TALOs