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

Last updated: December 3, 2024
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoproliferative Disorders

Hematologic Cancer

Treatment

N/A

Clinical Study ID

NCT06720870
SilOs
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed diagnosis of R/R MCD HIV and HHV-8 negative patients whounderwent 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

Exclusion Criteria:

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

Study Design

Total Participants: 65
Study Start date:
March 01, 2023
Estimated Completion Date:
January 31, 2025

Study 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.

Connect with a study center

  • Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico

    Bari, 70124
    Italy

    Active - Recruiting

  • IRCCS Azienda Ospedaliero - Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Sant'Anna e San Sebastiano

    Caserta, 81100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Ferrara, 44124
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Firenze, 50134
    Italy

    Active - Recruiting

  • Irccs Ospedale San Raffaele

    Milano, 20100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria "Maggiore della Carità"

    Novara, 28100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Di Padova

    Padova, 35128
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100
    Italy

    Active - Recruiting

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

    Treviso, 31100
    Italy

    Active - Recruiting

  • Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso

    Treviso, 31100
    Italy

    Active - Recruiting

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