Health TrialsbyHealthPanel

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

ConditionCastleman Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
after the end of siltuximab infusion

Secondary outcomes

1

Duration of response (DoR)

Duration of response (DoR)

Time frame
before, during and after the end of siltuximab infusion
2

Progression-free survival (PFS)

Progression-free survival (PFS)

Time frame
before, during and after the end of siltuximab infusion
3

Overall Survival (OS)

Overall Survival (OS)

Time frame
before, during and after the end of siltuximab infusion
4

Duration Free Survival (DFS)

Duration Free Survival (DFS)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

Source ClinicalTrials.gov
Apply now