Study in Patients With Relapsed/Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Mediastinal B Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Retrospective Observational Study in Patients With Relapsed / Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
Overview
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.
Primary outcome measures
- overall response rate (ORR) [Time frame: at the end of treatment, through study completion, an average of 2 years]
Secondary outcome measures (7)
- Duration of Response (DoR) [Time frame: through study completion, an average of 2 years]
- Progression Free Survival (PFS) [Time frame: through study completion, an average of 2 years]
- Overall Survival (OS) [Time frame: through study completion, an average of 2 years]
- Disease Free Survival (DFS) [Time frame: through study completion, an average of 2 years]
- Best response rate (BRR) [Time frame: through study completion, an average of 2 years]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: through study completion, an average of 2 years]
- Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability] [Time frame: through study completion, an average of 2 years]
Eligibility criteria
Inclusion criteria
- 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
- Age ≥ 18 years at enrollment
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna
- Azienda Ospedaliera Universitaria- POLICLINICO BARI — Bari
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
Identifiers
NCT: NCT06781450 · PRIMICI