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

Recruiting

• Conditions: Castleman Disease

• Registration Number: NCT06720870
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief 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.

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 Timeline

• Study Start: 2023-03-01
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall response rate (ORR)	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

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico; 🇮🇹 Bari, Italy

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy

Azienda Ospedaliera Sant'Anna e San Sebastiano; 🇮🇹 Caserta, Italy

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna; 🇮🇹 Ferrara, Italy

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

Irccs Ospedale San Raffaele; 🇮🇹 Milano, Italy

Azienda Ospedaliero-Universitaria "Maggiore della Carità"; 🇮🇹 Novara, Italy

Azienda Ospedaliera Di Padova; 🇮🇹 Padova, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy

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

Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso; 🇮🇹 Treviso, Italy