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NCT Number: 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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • R/R MCD patients who underwent siltuximab in a clinical trial context

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Duration of response (DoR)

    Time frame: before, during and after the end of siltuximab infusion

    Duration of response (DoR)

  2. Progression-free survival (PFS)

    Time frame: before, during and after the end of siltuximab infusion

    Progression-free survival (PFS)

  3. Overall Survival (OS)

    Time frame: before, during and after the end of siltuximab infusion

    Overall Survival (OS)

  4. Duration Free Survival (DFS)

    Time frame: before, during and after the end of siltuximab infusion

    Duration Free Survival (DFS)

  5. Best response rate (BRR)

    Time frame: before, during and after the end of siltuximab infusion

    Best response rate (BRR)

  6. safety and tolerability of siltuximab

    Time frame: before, during and after the end of siltuximab infusion

    safety and tolerability of siltuximab

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice Casadei, MD

CONTACT

[email protected]

+39 0512143680

Pier Luigi Zinzani, MD

CONTACT

[email protected]

+390512144042

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: SilOs

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

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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