International Registry for Patients With Castleman Disease
NCT02817997
Angiofollicular Lymph Hyperplasia, Angiofollicular Lymph Node Hyperplasia
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT Number: NCT06720870
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: before, during and after the end of siltuximab infusion
Duration of response (DoR)
Time frame: before, during and after the end of siltuximab infusion
Progression-free survival (PFS)
Time frame: before, during and after the end of siltuximab infusion
Overall Survival (OS)
Time frame: before, during and after the end of siltuximab infusion
Duration Free Survival (DFS)
Time frame: before, during and after the end of siltuximab infusion
Best response rate (BRR)
Time frame: before, during and after the end of siltuximab infusion
safety and tolerability of siltuximab
Contact information is provided by the study sponsor or research team.
Beatrice Casadei, MD
CONTACT
Pier Luigi Zinzani, MD
CONTACT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Acronym: SilOs
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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