Siltuximab (Sylvant®) Clinical Trial

A new clinical trial has opened for patients with idiopathic multicentric Castleman disease (iMCD), including iMCD-Thrombocytopenia/Anasarca/Fever/Reticulin fibrosis/Organomegaly (TAFRO), in the United States (US).

 A clinical trial to investigate the efficacy and safety of siltuximab dose escalation is open for patients with siltuximab-relapsed/refractory idiopathic HIV/HHV-8-negative multicentric Castleman disease (iMCD) and elevated and rising C-reactive protein (CRP) levels

 Patients with iMCD or iMCD-TAFRO whose disease has progressed after tolerating treatment with standard-dose siltuximab (Sylvant®) and with signs or symptoms of Castleman disease, including elevated and rising CRP levels, are eligible to enroll.

About the clinical trial

Dr. Luis Fayad,     Principal Investigator,  MD Anderson Cancer Center

EUSA Pharma will be conducting a research study of the approved medicine, siltuximab (Sylvant®), for adults and adolescents whose idiopathic multicentric Castleman disease (iMCD) has progressed on standard-dose siltuximab. Dr. Luis Fayad, MD Anderson Cancer Center, and Dr. Gordan Srkalovic, Sparrow Herbert-Herman Cancer Center are the Lead Principal Investigators for this study. Trial patients also need to have signs or symptoms of Castleman disease, including elevated and rising C-reactive protein (CRP) levels potentially indicative of excess circulating interleukin-6 (IL-6) that could use higher doses of siltuximab for more complete binding and neutralization. Participation in this study is entirely voluntary.

Who can enroll

Patients who meet the following criteria may be eligible to enroll in this clinical trial:

  • Confirmed diagnosis of idiopathic (HIV/HHV-8-negative) multicentric Castleman disease (iMCD) or iMCD-TAFRO by a physician
  • Are at least 12 years of age
  • Have previously taken and tolerated standard-dose siltuximab (Sylvant®) which did not work or stopped working
  • Have active disease with signs or symptoms of Castleman disease, including elevated and rising CRP levels, at the time of enrollment in the trial

How to enroll

Dr. Gordan Srkalovic, Principal Investigator, Sparrow Herbert-Herman Cancer Center

If you are interested in participating or have any questions about this study, please contact research staff:

Phone: +1-978-390-1834

Email: Melahat.Samali@eusapharma.com

Eligible participants will receive, at no cost, study-related:

  • Medical procedures
  • Laboratory assessments (lab tests/bloodwork)
  • Investigational medication (siltuximab)

Participants in the trial must enroll at one of the designated clinical trial sites in the US. Enrolled patients are required to travel to their chosen institution to receive siltuximab and be part of the clinical trial. Reimbursement for study travel is available for enrolled patients. Trial research staff will review detailed logistical information with you.

About siltuximab (Sylvant®)

Siltuximab (Sylvant®)is the only FDA-approved drug for the treatment of patients with Castleman disease. It works by blocking the action of an important protein calledinterleukin-6 (IL-6), a substance produced in the lymph nodes. Siltuximab is a monoclonal antibody that prevents IL-6 from binding to IL-6 receptors. It is normally administered at a hospital or clinic every 3 weeks through anintravenous infusion.

I still have questions. Where can I find answers?

Research staff are available to answer all questions and provide additional information.

Phone: +1-781-491-9581

Email: ClinicalR&D@eusapharma.com

Arrow Shape Facebook Instagram Twitter Youtube Play Arrow Left