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

NCT06781450 | Recruiting

• 1 other identifier: PRIMICI
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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

Conditions

Primary Mediastinal B Cell Lymphoma

Keywords

pembrolizumab; nivolumab; brentuximab 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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
• Age ≥ 18 years at enrollment
• Signature of written informed consent (where applicable)

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (3)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Azienda Ospedaliera Universitaria- POLICLINICO BARI

Bari, 70124, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, 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; cinzia.pellegrini@aosp.bo.it

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
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)