Actively Recruiting
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
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-06
65
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a retrospective observational study to collect and evaluate data from patients with relapsed or refractory Multicentric Castleman Disease (MCD) who were treated with siltuximab in real-life clinical settings across 31 Italian centers between July 2016 and April 2022. The study aims to provide more information on the use, effectiveness, and safety of siltuximab in this rare condition, based on data routinely collected during normal clinical practice without any additional interventions. This study involves reviewing medical records of patients who received at least one dose of siltuximab as part of their standard treatment. No new treatments or procedures will be administered as part of the study. Researchers will examine clinical variables and outcomes related to siltuximab treatment, focusing on how patients responded and tolerated the medication in everyday care. Participants' involvement consists of the collection of their existing medical data only, without any extra visits or procedures outside routine care. The main outcome measured is the overall response rate after siltuximab treatment. Secondary outcomes include duration of response, progression-free survival, overall survival, duration free survival, best response rate, and safety and tolerability of siltuximab. The study is observational and non-interventional, ensuring participants are monitored through their usual clinical records without additional study-related interventions.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of relapsed or refractory Multicentric Castleman Disease in HIV and HHV-8 negative patients who received siltuximab treatment between July 2016 and April 2022
- Age 18 years or older at enrollment
- Signed written informed consent where applicable
You will not qualify if you...
- Patients with relapsed or refractory Multicentric Castleman Disease who received siltuximab as part of a clinical trial context
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Retrospective period covering treatment from July 2016 to April 2022
Participants who undergo routine care are observed with clinical variables collected before, during, and after siltuximab infusion to assess effectiveness and safety in a real-life context.
Visits as per routine clinical practice
Trial Site Locations
Total: 12 locations
1
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
2
Azienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, Caserta, Italy, 81100
Actively Recruiting
3
Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy, 70124
Actively Recruiting
4
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, Italy, 44124
Actively Recruiting
5
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
6
Irccs Ospedale San Raffaele
Milan, Italy, 20100
Actively Recruiting
7
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, Italy, 28100
Actively Recruiting
8
Azienda Ospedaliera Di Padova
Padova, Italy, 35128
Actively Recruiting
9
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
10
Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
Actively Recruiting
11
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, 31100
Actively Recruiting
12
Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso
Treviso, Italy, 31100
Actively Recruiting
Research Team
P
Pier Luigi Zinzani, MD
B
Beatrice Casadei, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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