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The study is pilot, observational, retrospective, Italian multicenter study.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | the secondary aim is to evaluate effectiveness of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017) | through study completion, an average of 2 years |
| Toxicity of study drug |
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Inclusion Criteria:
Exclusion Criteria:
1) R/R DLBCL patients who received tafasitamab in association with lenalidomide in a clinical trial context.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pier Luigi Zinzani, MD | Contact | +39 0512144042 | pierluigi.zinzani@unibo.it | |
| Beatrice Casadei, MD | Contact | +39 0512143680 | beatrice.casadei@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Pier Luigi Zinzani, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero - Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
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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
| from enrollment untill 30 days from last infusion |
| Progression Free Survival (PFS) | 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. | through study completion, an average of 2 years |
| Overall Survival (OS) | Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause. | through study completion, an average of 2 years |
| Duration Free Survival (DFS) | Disease free survival (DFS) is defined as the time from randomization until evidence of disease recurrence | through study completion, an average of 2 years |
| Best response rate (BRR) | Best response rate (BRR) | through study completion, an average of 2 years |
| AO Sant'Anna e San Sebastiano di Caserta | Recruiting | Caserta | Caserta | Italy |
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| A.R.N.A.S. Garibaldi | Recruiting | Catania | Catania | Italy |
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| Azienda Ospedaliera Universitaria Arcispedale S. Anna | Recruiting | Ferrara | Italy |
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| Azienda Ospedaliero Universitaria Careggi | Recruiting | Florence | 50134 | Italy |
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| Irccs Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
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| Azienda Ospedaliero-Universitaria Maggiore della Carità | Recruiting | Novara | 28100 | Italy |
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| Azienda Ospedaliera Villa Sofia Cervello | Recruiting | Palermo | 90146 | Italy |
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| Ospedale Guglielmo da Saliceto di Piacenza | Recruiting | Piacenza | 29100 | Italy |
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| IRCCS- Istituto Nazionale Tumori Regina Elena | Recruiting | Roma | 00144 | Italy |
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| Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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