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

NCT ID: NCT06781450

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-23

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Primary Mediastinal B Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Age ≥ 18 years at enrollment
3. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pier Luigi Zinzani, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria- POLICLINICO BARI

Bari, , Italy

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pier Luigi Zinzani, MD

Role: CONTACT

+390512144042

Cinzia Pellegrini, MD

Role: CONTACT

+390512143680

Facility Contacts

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Pier Luigi Zinzani, MD

Role: primary

+390512144042

Cinzia Pellegrini, MD

Role: backup

+390512143680

Pellegrino Musto, MD

Role: primary

+39 0805593471

Francesco Gaudio, MD

Role: backup

Paolo Corradini, MD

Role: primary

+39 0223902950

Anna Guidetti, MD

Role: backup

+39 0223902175

Other Identifiers

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PRIMICI

Identifier Type: -

Identifier Source: org_study_id

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