Castleman Disease
Conditions
Keywords
Siltuximab
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 of response (DoR) | before, during and after the end of siltuximab infusion | Duration of response (DoR) |
| 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 |
| Duration Free Survival (DFS) | before, during and after the end of siltuximab infusion | Duration Free Survival (DFS) |
Countries
Italy
Contacts
Primary ContactPier Luigi Zinzani, MD
Backup ContactBeatrice Casadei, MD
Outcome results
None listed