Castleman DiseaseSilOsNCT06720870
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
An observational study of Castleman Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 12 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Castleman Disease
- How many people
- 65 participants
- Where
- 12 sitesItaly
- Study dates
- 1 Mar 2023to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Age ≥ 18 yearsatenrollment
- Signature of written informed consent (where applicable)
Who cannot join
- 1. R/R MCD patients who underwent siltuximab in a clinical trial context
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites, 12 recruiting
- Recruiting
Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, 70124
Pellegrino Musto, MD, +39 0805593471, pellegrino.musto@uniba.it
Tommasina Perrone, MD, +39 0805594143, tommasina.perrone@virgilio.it
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, 40138
Pier Luigi Zinzani, MD, +390512144042, pierluigi.zinzani@unibo.it
Beatrice Casadei, MD, +39 0512143680, beatrice.casadei@aosp.bo.it
- Recruiting
Azienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, Caserta, 81100
Giusy Cetani, MD, +390823232935, giusy.cetani@aorncaserta.it
Salvatore Iaccarino, MD, +390823232935, salvatore.iaccarino@aorncaserta.it
- Recruiting
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, 44124
Antonio Cuneo, MD, +390532236977, cut@unife.it
Antonio Cuneo, MD
- Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Luca Nassi, MD, +39 0557947358, nassil@aou-careggi.toscana.it
Marianna Palazzo, MD, +39 055 7947358, marianna.palazzo@unifi.it
- Recruiting
Irccs Ospedale San Raffaele
Milan, 20100
Andrés JM Ferreri, MD, +39 0226437649, ferreri.andres@hsr.it
Fabrizio Marino, MD, +39 0226437649, marino.fabrizio@hsr.it
- Recruiting
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, 28100
Riccardo Bruna, MD, +39 03213733127, riccardo.bruna@maggioreosp.novara.it
Gloria Margiotta Casalucci, MD, +39 03213733094
- Recruiting
Azienda Ospedaliera Di Padova
Padova, 35128
Fabrizio Vianello, MD, 349 2310090, fabrizio.vianello@unipd.it
Chiara Adele Cavarretta, MD, chiaraadele.cavarretta@aopd.veneto.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Luca Arcaini, MD, +39 0382503689, l.arcaini@sanmatteo.pv.it
Cristinelli, MD, +39 0382503084
- Recruiting
Azienda Ospedaliera Universitaria Senese
Siena, 53100
Emanuele Cencini, MD, +39 0577586185, cencioema@libero.it
Alberto Fabbri, MD, +39 0577586786, fabbri7@unisi.it
- Recruiting
Azienda ULSS 2 Marca Trevigiana - UOC Medicina Interna 1 Centro di Riferimento per le Malattie Rare del Sistema Immunitario e dell'Apparato Respiratorio
Treviso, 31100
Francesco Cinetto, MD, +39 0422 3228145, francesco.cinetto@unipd.it
Riccardo Scarpa, MD, +39 0422 3228115, riccardo.scarpa@unipd.it
- Recruiting
Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso
Treviso, 31100
Piero Maria Stefani, MD, +39 0422322368, pieromaria.stefani@aulss2.veneto.it
Piero Maria Stefani, MD
About this study
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.
Read the 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.
- Conditions
- Castleman Disease
- Keywords
- Siltuximab
- Medical subject headings
- Castleman Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
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
Measured: after the end of siltuximab infusion
Secondary outcomes (6)
Duration of response (DoR)
Duration of response (DoR)
Measured: before, during and after the end of siltuximab infusion
Progression-free survival (PFS)
Progression-free survival (PFS)
Measured: before, during and after the end of siltuximab infusion
Overall Survival (OS)
Overall Survival (OS)
Measured: before, during and after the end of siltuximab infusion
Duration Free Survival (DFS)
Duration Free Survival (DFS)
Measured: before, during and after the end of siltuximab infusion
Best response rate (BRR)
Best response rate (BRR)
Measured: before, during and after the end of siltuximab infusion
safety and tolerability of siltuximab
safety and tolerability of siltuximab
Measured: before, during and after the end of siltuximab infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Mar 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castleman DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720870
- Sponsor's protocol ID
- SilOs
- Acronym
- SilOs
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06720870
- Acronym / sponsor ID
- SilOs / SilOs
- Conditions
- Castleman Disease
- Keywords
- Siltuximab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- Age ≥ 18 yearsatenrollment
- Signature of written informed consent (where applicable)
Key exclusion criteria (1 listed)
- 1. R/R MCD patients who underwent siltuximab in a clinical trial context
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall response rate (ORR)
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
6 secondary outcomes
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
Time frame: before, during and after the end of siltuximab infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Castleman Disease
Active, not recruitingPhase 1
Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma
Kaposi Sarcoma
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
RecruitingPhase 2
Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)
KSHV Inflammatory Cytokine Syndrome (KICS), Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease
RecruitingObservational study
Natural History of KSHV-Associated Multicentric Castleman s Disease
Multicentric Castleman s Disease
RecruitingObservational study
Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
HIV, Kaposi's Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pier Luigi Zinzani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Castleman Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+390512144042, pierluigi.zinzani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (ORR) (time frame: after the end of siltuximab infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.