An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Siltuximab for Patients with Castleman's Disease Treated in Italy in a Real-life Context

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

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-01-31

Brief Summary

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The study is a pilot, observational, retrospective, and (italian) multicenter study.

The study will involve the collection of patient data from medical records for patients with Multicentric Castelman Disease Relapsed/Refractory who received treatment with at least one dose of siltuximab, as part of standard of care in a real-life context, from July 2016 till April 2022 in 31selected italian centres.

Detailed Description

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The aim of the present study is to provide useful information about use, effectiveness, and safety profile of siltuximab given to relapsed or refractory (R/R) MCD in a real-life context since approval as more data are needed to improve knowledge in this rare disease. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. Infact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.

Conditions

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Castleman Disease

Keywords

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Siltuximab

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 R/R MCD HIV and HHV-8 negative patients who underwent siltuximab in a real-life context from July 2016 till April 2022.
2. Age ≥ 18 yearsatenrollment
3. Signature of written informed consent (where applicable)

Exclusion Criteria

1\. R/R MCD patients who underwent siltuximab in a clinical trial context

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

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Pier Luigi Zinzani, MD

Role: CONTACT

Phone: +390512144042

Role: backup

Other Identifiers

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SilOs

Identifier Type: -

Identifier Source: org_study_id

An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Siltuximab for Patients with Castleman's Disease Treated in Italy in a Real-life Context

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Responsible Party

Principal Investigators

Pier Luigi Zinzani, MD

Locations

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Azienda Ospedaliera Sant'Anna e San Sebastiano

Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

Azienda Ospedaliero Universitaria Careggi

Irccs Ospedale San Raffaele

Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Azienda Ospedaliera Di Padova

Fondazione IRCCS Policlinico San Matteo

Azienda Ospedaliera Universitaria Senese

Azienda ULSS 2 Marca Trevigiana - UOC Medicina Interna 1 Centro di Riferimento per le Malattie Rare del Sistema Immunitario e dell'Apparato Respiratorio

Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso

Countries

Central Contacts

Pier Luigi Zinzani, MD

Beatrice Casadei, MD

Facility Contacts

Pier Luigi Zinzani, MD

Beatrice Casadei, MD

Pier Luigi Zinzani, MD

Giusy Cetani, MD

Salvatore Iaccarino, MD

Giusy Cetani, MD

Pellegrino Musto, MD

Tommasina Perrone, MD

Pellegrino Musto, MD

Antonio Cuneo, MD

Antonio Cuneo, MD

Luca Nassi, MD

Marianna Palazzo, MD

Luca Nassi, MD

Andrés JM Ferreri, MD

Fabrizio Marino, MD

Andrés JM Ferreri, MD

Riccardo Bruna, MD

Gloria Margiotta Casalucci, MD

Fabrizio Vianello, MD

Chiara Adele Cavarretta, MD

Fabrizio Vianello, MD

Luca Arcaini, MD

Cristinelli, MD

Luca Arcaini, MD

Emanuele Cencini, MD

Alberto Fabbri, MD

Emanuele Cencini, MD

Francesco Cinetto, MD

Riccardo Scarpa, MD

Francesco Cinetto, MD

Piero Maria Stefani, MD

Piero Maria Stefani, MD

Other Identifiers

SilOs