Trials Sponsors Conditions Drugs Pricing

Conditions

Primary Mediastinal B Cell Lymphoma

Keywords

pembrolizumabnivolumabbrentuximab vedotin

Outcome Measures

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

Secondary Outcomes (7)

Duration of Response (DoR)
through study completion, an average of 2 years
Progression Free Survival (PFS)
through study completion, an average of 2 years
Overall Survival (OS)
through study completion, an average of 2 years
Disease Free Survival (DFS)
through study completion, an average of 2 years
Best response rate (BRR)
through study completion, an average of 2 years
+2 more secondary outcomes

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study 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

You may qualify if:

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

Sponsors & Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Otherlead

Study Sites (3)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Pier Luigi Zinzani, MDCONTACT+390512144042 pierluigi.zinzani@unibo.it

Cinzia Pellegrini, MDCONTACT+390512143680 cinzia.pellegrini@aosp.bo.it

Pier Luigi Zinzani, MDPRINCIPAL INVESTIGATOR

Azienda Ospedaliera Universitaria- POLICLINICO BARI

Bari, 70124, Italy

RECRUITING

Study Officials

Pier Luigi Zinzani, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+390512144042 pierluigi.zinzani@unibo.it

Cinzia Pellegrini, MD

CONTACT

+390512143680

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

January 17, 2025

Study Start

April 23, 2022

Actual (reported)

Primary Completion

December 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations