Assessing the effectiveness and safety of siltuximab for Castleman's Disease in Italy

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

This study looks at how well and safely siltuximab works for people in Italy with relapsed or refractory Multicentric Castleman Disease by reviewing their medical records.

Quick facts

• Study type: Observational
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Academic / other)
• Drugs / interventions: siltuximab
• Locations: 12 sites (Bologna, Bologna and 11 other locations)
• Trial ID: NCT06720870 on ClinicalTrials.gov

What this trial studies

This observational study collects and analyzes patient data from medical records of individuals with relapsed or refractory Multicentric Castleman Disease who received siltuximab treatment in Italy from July 2016 to April 2022. The study aims to evaluate the real-life effectiveness and safety profile of siltuximab, providing insights into its use in clinical practice without any additional interventions. By focusing on a multicenter approach, the study seeks to gather comprehensive data from 31 selected Italian centers to enhance understanding of this rare disease.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a histologically confirmed diagnosis of relapsed or refractory Multicentric Castleman Disease who have received siltuximab.

Not a fit: Patients who have received siltuximab as part of a clinical trial will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of siltuximab for patients with Castleman's Disease.

How similar studies have performed: While this study is observational and retrospective, similar studies have shown promise in evaluating treatment effectiveness in real-world settings, although this specific approach may be novel.

Eligibility criteria

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

Where this trial is running

Bologna, Bologna and 11 other locations

• IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
• Azienda Ospedaliera Sant'Anna e San Sebastiano — Caserta, Caserta, Italy (Recruiting)
• Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari, Italy (Recruiting)
• Azienda Ospedaliera Universitaria Arcispedale Sant'Anna — Ferrara, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Recruiting)
• Irccs Ospedale San Raffaele — Milan, Italy (Recruiting)
• Azienda Ospedaliero-Universitaria "Maggiore della Carità" — Novara, Italy (Recruiting)
• Azienda Ospedaliera Di Padova — Padova, Italy (Recruiting)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
• Azienda Ospedaliera Universitaria Senese — Siena, Italy (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, Italy (Recruiting)
• Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso — Treviso, Italy (Recruiting)

Study contacts

• Principal investigator: Pier Luigi Zinzani, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Pier Luigi Zinzani, MD

Conditions Castleman Disease; Siltuximab