Primary Mediastinal B Cell Lymphoma
Conditions
Keywords
pembrolizumab, nivolumab, brentuximab vedotin
Brief summary
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
Detailed description
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 * To assess efficacy, in terms of: * Duration of response (DoR) * Progression-free survival (PFS) * Overall survival (OS) * Disease-free survival (DFS) * Best response rate (achieved at any time during treatment) * To evaluate the safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin The study will include 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 setting from November 2020 until November 2021.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed diagnosis of Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021 2. Age ≥ 18 years at enrollment 3. Signature of written informed consent (where applicable)
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate (ORR) | at the end of treatment, through study completion, an average of 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | through study completion, an average of 2 years | Progression Free Survival (PFS) |
| Overall Survival (OS) | through study completion, an average of 2 years | Overall Survival (OS) |
| Disease Free Survival (DFS) | through study completion, an average of 2 years | Disease Free Survival (DFS) |
| Duration of Response (DoR) | through study completion, an average of 2 years | Duration of Response (DoR) |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | through study completion, an average of 2 years | safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin |
| Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability] | through study completion, an average of 2 years | safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin |
| Best response rate (BRR) | through study completion, an average of 2 years | Best response rate (BRR) |
Countries
Italy
Contacts
Primary ContactPier Luigi Zinzani, MD
Backup ContactCinzia Pellegrini, MD
Outcome results
None listed