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 * 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.
Study Type
OBSERVATIONAL
Enrollment
50
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, Italy
RECRUITINGAzienda Ospedaliera Universitaria- POLICLINICO BARI
Bari, Italy
RECRUITINGFondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
RECRUITINGoverall 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
Time frame: at the end of treatment, through study completion, an average of 2 years
Duration of Response (DoR)
Duration of Response (DoR)
Time frame: through study completion, an average of 2 years
Progression Free Survival (PFS)
Progression Free Survival (PFS)
Time frame: through study completion, an average of 2 years
Overall Survival (OS)
Overall Survival (OS)
Time frame: through study completion, an average of 2 years
Disease Free Survival (DFS)
Disease Free Survival (DFS)
Time frame: through study completion, an average of 2 years
Best response rate (BRR)
Best response rate (BRR)
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 2 years
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