NCT06720870

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 6, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

December 3, 2024

Last Update Submit

December 3, 2024

Conditions

Castleman Disease

Keywords

Siltuximab

Outcome Measures

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

    after the end of siltuximab infusion

Secondary Outcomes (6)

  • Duration of response (DoR)

    before, during and after the end of siltuximab infusion

  • Progression-free survival (PFS)

    before, during and after the end of siltuximab infusion

  • Overall Survival (OS)

    before, during and after the end of siltuximab infusion

  • Duration Free Survival (DFS)

    before, during and after the end of siltuximab infusion

  • Best response rate (BRR)

    before, during and after the end of siltuximab infusion

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Azienda Ospedaliera Sant'Anna e San Sebastiano

Caserta, Caserta, 81100, Italy

RECRUITING

Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, 70124, Italy

RECRUITING

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

Ferrara, 44124, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Irccs Ospedale San Raffaele

Milan, 20100, Italy

RECRUITING

Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Novara, 28100, Italy

RECRUITING

Azienda Ospedaliera Di Padova

Padua, 35128, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

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, Italy

RECRUITING

Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso

Treviso, 31100, Italy

RECRUITING

MeSH Terms

Conditions

Castleman Disease

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Pier Luigi Zinzani, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+390512144042pierluigi.zinzani@unibo.it

Beatrice Casadei, MD

CONTACT

+39 0512143680beatrice.casadei@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

March 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

December 6, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(12)