Clinical trial NCT06720870: 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
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Castleman Disease
Keywords: Siltuximab
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: overall response rate (ORR)
timeFrame: after the end of siltuximab infusion
Secondary outcomes:
measure: Duration of response (DoR)
timeFrame: before, during and after the end of siltuximab infusion
measure: Progression-free survival (PFS)
timeFrame: before, during and after the end of siltuximab infusion
measure: Overall Survival (OS)
timeFrame: before, during and after the end of siltuximab infusion
measure: Duration Free Survival (DFS)
timeFrame: before, during and after the end of siltuximab infusion
measure: Best response rate (BRR)
timeFrame: before, during and after the end of siltuximab infusion
measure: safety and tolerability of siltuximab
timeFrame: before, during and after the end of siltuximab infusion
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
city: Caserta
country: Italy
facility: Azienda Ospedaliera Sant'Anna e San Sebastiano
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria "Maggiore della Carità"
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Treviso
country: Italy
facility: Azienda ULSS 2 Marca Trevigiana - UOC Medicina Interna 1 Centro di Riferimento per le Malattie Rare del Sistema Immunitario e dell'Apparato Respiratorio
city: Treviso
country: Italy
facility: Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: