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Study in Patients With Relapsed/Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context

ConditionPrimary Mediastinal B Cell Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
at the end of treatment, through study completion, an average of 2 years

Secondary outcomes

1

Duration of Response (DoR)

Duration of Response (DoR)

Time frame
through study completion, an average of 2 years
2

Progression Free Survival (PFS)

Progression Free Survival (PFS)

Time frame
through study completion, an average of 2 years
3

Overall Survival (OS)

Overall Survival (OS)

Time frame
through study completion, an average of 2 years
4

Disease Free Survival (DFS)

Disease Free Survival (DFS)

Time frame
through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

Source ClinicalTrials.gov
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