Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Observational, Non-Interventional, Retrospective, Multicenter Study Focusing on the Efficacy and Safety of Pembrolizumab Monotherapy and Nivolumab in Combination With Brentuximab Vedotin in Clinical Practice Patients With Primary Mediastinal B Cell Lymphoma Relapsed/Refractory
Observational, non-interventional, retrospective, multicentre study focusing on the efficacy and safety of pembrolizumab as monotherapy and nivolumab in combination with brentuximab vedotin in daily clinical practice in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory. The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, sum of complete response rate [CR] and partial response rate [PR]) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/RefractoryL treated in a real-life setting from November 2020 until November 2021.
Secondary objectives
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR) | The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, the sum of complete response [CR] and partial response [PR] rate) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated in a real-life setting from November 2020 through November 2021 | at the end of treatment, through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | Duration of Response (DoR) | through study completion, an average of 2 years |
| Progression Free Survival (PFS) | Progression Free Survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a clinical trial context.
Not provided
Not provided
Not provided
Patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pier Luigi Zinzani, MD | Contact | +390512144042 | pierluigi.zinzani@unibo.it | |
| Cinzia Pellegrini, MD | Contact | +390512143680 | cinzia.pellegrini@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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| through study completion, an average of 2 years |
| Overall Survival (OS) | Overall Survival (OS) | through study completion, an average of 2 years |
| Disease Free Survival (DFS) | Disease Free Survival (DFS) | through study completion, an average of 2 years |
| Best response rate (BRR) | Best response rate (BRR) | through study completion, an average of 2 years |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin | through study completion, an average of 2 years |
| Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability] | safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin | through study completion, an average of 2 years |
| Azienda Ospedaliera Universitaria- POLICLINICO BARI | Recruiting | Bari | 70124 | Italy |
|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
|