Evaluate the Safety of Long-term Treatment with CNTO328 in MCD
Research type
Research Study
Full title
An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castleman's Disease
IRAS ID
113789
Contact name
Stephen Schey
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2010-022837-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Multicentric Castleman’s Disease (MCD) is a very rare disease characterized by noncancerous growths (tumours) that may develop in the lymph node tissue throughout the body. Treatment goals include alleviation of debilitating symptoms that contribute to shortened survival, and reduction of tumour masses. Patients with MCD are usually managed by treatment of symptoms, with only modest success being reported. No treatment consistently results in a reduction in tumour burden, and median survival is therefore short.
There is an unmet medical need for effective treatment in MCD.
A Phase 1-2 study, C0328T03 showed encouraging results in the cohort of patients with Castlemans Disease (See more detail in A62). As a result, a Phase 2 efficacy study in patients with MCD was set up and will reach completion shortly. The study currently submitted for approval CNTO328MCD2002 is designed to evaluate the longterm safety in MCD subjects who were previously enrolled in sponsor initiated studies of Multicentric Castleman’s Disease (C0328T03 and CNTO328MCD2001) and are either Siltuximab naïve or have not progressed on Siltuximab in the opinion of the investigator and are experiencing benefit from treatment. Siltuximab is an investigational agent and further evaluation is necessary to better understand the long-term safety of siltuximab in this population.
Up to 75 subjects will be eligible, the majority of whom will be on active therapy with Siltuximab at the time of enrolment. All subjects will be treated with Siltuximab 11 mg / kg every 3 weeks. The treatment period interval may be lengthened to 6 weeks at the investigator’s discretion for subjects with confirmed partial or complete response of more than 6 months duration.
All subjects will be treated until they progress, withdraw consent, experience unacceptable toxicity, or until 4 years after the first subject in any other country started treatment in the study, whichever comes first. Subjects who discontinue treatment will have follow up assessments for survival, occurrence of malignancies and subsequent therapies for Multicentric Castleman’s Disease. A data cutoff will occur 5 years after the first subject is enrolled.
The end of study is the date of the last assessment for the last subject (e.g., last survival follow up).
The Christie Hospital will be the only UK site participating, potentially enrolling 2 subjects from the CNTO328MCD2001 study.REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/0023
Date of REC Opinion
15 Feb 2013
REC opinion
Further Information Favourable Opinion