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Study designobservational, non-interventional, retrospective, multicenter study.
The study focusing on information about the effectiveness and safety of polatuzumab vedotin plus rituximab (± bendamustine) in patients who received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the NPP (D.M. 7 Sep 2017) programme in the period between June 2019 and Feb 2020 in Italy.
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| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR) | Effectiveness of polatuzumab vedotin plus rituximab (± bendamustine) in patients with relapsed or refractory DLBCL who have received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the NPP (D.M. 7 Sep 2017) in the period between June 2019 and Feb 2020 in Italy. This value is calculated as the sum of partial (PRR) and complete response rates (CRR) at end of treatment. | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | is the length of time from either the date of diagnosis or the start of treatment ... | through study completion, an average of 2 years |
| Progression Free Survival (PFS) | the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease |
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Inclusion Criteria:
Exclusion Criteria:
Patients with DLBCL treated with polatuzumab vedotin plus rituximab (± bendamustine) within a clinical trial context
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DLBCL patients who received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the NPP (D.M. 7 Sep 2017) programme in the period between June 2019 and Feb 2020 in Italy.
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| 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 | Bologna | Bologna | 40138 | Italy | ||
| Casa Sollievo della Sofferenza - Reparto di Oncoematologia |
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| through study completion, an average of 2 years |
| disease free survival (DFS) at 6 months | the time from random assignment to cancer recurrence or death from any cause. | through study completion, an average of 2 years |
| frequency distribution of the causes of death | frequency | through study completion, an average of 2 years |
| Mean treatment duration | Mean treatment duration | through study completion, an average of 2 years |
| Incidence and type of adverse events and severe adverse events | Incidence | through study completion, an average of 2 years |
| Proportion of patients with clinical disease progression | Proportion | through study completion, an average of 2 years |
| Proportion of patients requiring one or more emergency department visits, hospitalizations, use of hematopoietic growth factors and antibiotics, and blood product transfusions | Proportion of patients with clinical disease progression | through study completion, an average of 2 years |
| Best response rate (BRR) | Best response rate (BRR) | through study completion, an average of 2 years |
| frequency distribution of the causes of treatment discontinuation | frequency distribution of the causes of treatment discontinuation | through study completion, an average of 2 years |
| San Giovanni Rotondo |
| Foggia |
| 71013 |
| Italy |
| Azienda Ospedaliera Universitaria- Policlinico di Bari | Bari | 70124 | Italy |
| Ospedale Oncologico Armando Businco | Cagliari | 09121 | Italy |
| Ospedale Maggiore della Carità | Novara | 28100 | Italy |
| Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello" | Palermo | 90146 | Italy |
| CORE IRCCS Arcispedale Santa Maria Nuova | Reggio Emilia | 42123 | Italy |
| Azienda Ospedaliera Santa Maria - SC di Oncoematologia | Terni | 05100 | Italy |
| ULSS2 - Ospedale Civile Ca' Foncello - UO Ematologia | Treviso | 31100 | Italy |
| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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