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 (SilOs)

December 3, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Recruiting

Conditions

Castleman Disease

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pier Luigi Zinzani, MD
Phone Number: +390512144042
Email: pierluigi.zinzani@unibo.it

Study Contact Backup

Name: Beatrice Casadei, MD
Phone Number: +39 0512143680
Email: beatrice.casadei@aosp.bo.it

Study Locations

Italy
- - Bari, Italy, 70124
    - Recruiting
    - Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico
    - Contact:
      
      Pellegrino Musto, MD
    - Contact:
      
      Pellegrino Musto, MD
      
      Phone Number: +39 0805593471
      
      Email: pellegrino.musto@uniba.it
    - Contact:
      
      Tommasina Perrone, MD
      
      Phone Number: +39 0805594143
      
      Email: tommasina.perrone@virgilio.it
  - Bologna, Italy, 40138
    - Recruiting
    - IRCCS Azienda Ospedaliero - Universitaria di Bologna
    - Contact:
      
      Pier Luigi Zinzani, MD
    - Contact:
      
      Pier Luigi Zinzani, MD
      
      Phone Number: +390512144042
      
      Email: pierluigi.zinzani@unibo.it
    - Contact:
      
      Beatrice Casadei, MD
      
      Phone Number: +39 0512143680
      
      Email: beatrice.casadei@aosp.bo.it
  - Caserta, Italy, 81100
    - Recruiting
    - Azienda Ospedaliera Sant'Anna e San Sebastiano
    - Contact:
      
      Giusy Cetani, MD
      
      Phone Number: +390823232935
      
      Email: giusy.cetani@aorncaserta.it
    - Contact:
      
      Salvatore Iaccarino, MD
      
      Phone Number: +390823232935
      
      Email: salvatore.iaccarino@aorncaserta.it
    - Contact:
      
      Giusy Cetani, MD
  - Ferrara, Italy, 44124
    - Recruiting
    - Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
    - Contact:
      
      Antonio Cuneo, MD
    - Contact:
      
      Antonio Cuneo, MD
      
      Phone Number: +390532236977
      
      Email: cut@unife.it
  - Firenze, Italy, 50134
    - Recruiting
    - Azienda Ospedaliero Universitaria Careggi
    - Contact:
      
      Luca Nassi, MD
    - Contact:
      
      Luca Nassi, MD
      
      Phone Number: +39 0557947358
      
      Email: nassil@aou-careggi.toscana.it
    - Contact:
      
      Marianna Palazzo, MD
      
      Phone Number: +39 055 7947358
      
      Email: marianna.palazzo@unifi.it
  - Milano, Italy, 20100
    - Recruiting
    - IRCCS Ospedale San Raffaele
    - Contact:
      
      Andrés JM Ferreri, MD
    - Contact:
      
      Andrés JM Ferreri, MD
      
      Phone Number: +39 0226437649
      
      Email: ferreri.andres@hsr.it
    - Contact:
      
      Fabrizio Marino, MD
      
      Phone Number: +39 0226437649
      
      Email: marino.fabrizio@hsr.it
  - Novara, Italy, 28100
    - Recruiting
    - Azienda Ospedaliero-Universitaria "Maggiore della Carità"
    - Contact:
      
      Riccardo Bruna, MD
      
      Phone Number: +39 03213733127
      
      Email: riccardo.bruna@maggioreosp.novara.it
    - Contact:
      
      Gloria Margiotta Casalucci, MD
      
      Phone Number: +39 03213733094
  - Padova, Italy, 35128
    - Recruiting
    - Azienda Ospedaliera di Padova
    - Contact:
      
      Fabrizio Vianello, MD
      
      Phone Number: 349 2310090
      
      Email: fabrizio.vianello@unipd.it
    - Contact:
      
      Chiara Adele Cavarretta, MD
      
      Email: chiaraadele.cavarretta@aopd.veneto.it
    - Contact:
      
      Fabrizio Vianello, MD
  - Pavia, Italy, 27100
    - Recruiting
    - Fondazione IRCCS Policlinico San Matteo
    - Contact:
      
      Luca Arcaini, MD
    - Contact:
      
      Luca Arcaini, MD
      
      Phone Number: +39 0382503689
      
      Email: l.arcaini@sanmatteo.pv.it
    - Contact:
      
      Cristinelli, MD
      
      Phone Number: +39 0382503084
  - Siena, Italy, 53100
    - Recruiting
    - Azienda Ospedaliera Universitaria Senese
    - Contact:
      
      Emanuele Cencini, MD
      
      Phone Number: +39 0577586185
      
      Email: cencioema@libero.it
    - Contact:
      
      Alberto Fabbri, MD
      
      Phone Number: +39 0577586786
      
      Email: fabbri7@unisi.it
    - Contact:
      
      Emanuele Cencini, MD
  - Treviso, Italy, 31100
    - Recruiting
    - Azienda ULSS 2 Marca Trevigiana - UOC Medicina Interna 1 Centro di Riferimento per le Malattie Rare del Sistema Immunitario e dell'Apparato Respiratorio
    - Contact:
      
      Francesco Cinetto, MD
      
      Phone Number: +39 0422 3228145
      
      Email: francesco.cinetto@unipd.it
    - Contact:
      
      Riccardo Scarpa, MD
      
      Phone Number: +39 0422 3228115
      
      Email: riccardo.scarpa@unipd.it
    - Contact:
      
      Francesco Cinetto, MD
  - Treviso, Italy, 31100
    - Recruiting
    - Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso
    - Contact:
      
      Piero Maria Stefani, MD
      
      Phone Number: +39 0422322368
      
      Email: pieromaria.stefani@aulss2.veneto.it
    - Contact:
      
      Piero Maria Stefani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with R/R MCD who receive at least one dose of siltuximab in a real-life context from July 2016 till April 2022.

Description

Inclusion Criteria:

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.
Age ≥ 18 yearsatenrollment
Signature of written informed consent (where applicable)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate (ORR) Time Frame: after the end of siltuximab infusion	Primarily this study aims to evaluate retrospectively effectiveness in terms of ORR of siltuximab as a single agent in patients with R/R MCD treated with at least one dose of siltuximab in a real-life context	after the end of siltuximab infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (DoR) Time Frame: before, during and after the end of siltuximab infusion	Duration of response (DoR)	before, during and after the end of siltuximab infusion
Progression-free survival (PFS) Time Frame: before, during and after the end of siltuximab infusion	Progression-free survival (PFS)	before, during and after the end of siltuximab infusion
Overall Survival (OS) Time Frame: before, during and after the end of siltuximab infusion	Overall Survival (OS)	before, during and after the end of siltuximab infusion
Duration Free Survival (DFS) Time Frame: before, during and after the end of siltuximab infusion	Duration Free Survival (DFS)	before, during and after the end of siltuximab infusion
Best response rate (BRR) Time Frame: before, during and after the end of siltuximab infusion	Best response rate (BRR)	before, during and after the end of siltuximab infusion
safety and tolerability of siltuximab Time Frame: before, during and after the end of siltuximab infusion	safety and tolerability of siltuximab	before, during and after the end of siltuximab infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Siltuximab

Additional Relevant MeSH Terms

Other Study ID Numbers

SilOs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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 (SilOs)

Study Overview

Status

Conditions

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Castleman Disease

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