Sirolimus Clinical Trial

A new clinical trial has opened for patients with idiopathic multicentric Castleman disease at the University of Pennsylvania and University of Arkansas for Medical Sciences

A clinical trial for the medication sirolimus is open for patients with idiopathic/HHV-8-negative multicentric Castleman disease (iMCD)

Patients with idiopathic (HHV-8-negative) multicentric Castleman disease who still have significant symptoms after trying either siltuximab or tocilizumab are eligible to enroll

About the clinical trial

Dr. David Fajgenbaum, Principal Investigator, University of Pennsylvania

The Castleman Disease Collaborative Network (CDCN) has partnered with the University of Pennsylvania and the University of Arkansas for Medical Sciences to conduct a research study of an investigational medicine, sirolimus, for adults who have idiopathic multicentric Castleman disease (iMCD) and are unable to benefit from anti-IL-6 therapies. Anti-IL-6 therapies are siltuximab (Sylvant) and tocilizumab (Actemra). 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:

  • Officially diagnosed with idiopathic (HHV-8-negative) multicentric Castleman disease by a physician
  • are between the ages of 18 and 80
  • have previously taken either siltuximab (Sylvant) or tocilizumab (Actemra) and did not have significant disease improvement while taking these medications OR were not able to stay on these medications due to severe side effects or allergic reaction
  • have active disease with signs and symptoms of Castleman disease at the time of enrollment in the trial

How to enroll

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

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

  • Medical procedures
  • Laboratory assessments (lab tests/bloodwork)
  • Investigational medication (sirolimus)
  • Reimbursement for study travel is available

Participants in the trial must enroll at either the University of Pennsylvania or the University of Arkansas for Medical Sciences. Enrolled patients are required to travel to their chosen institution to receive sirolimus 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 sirolimus

Dr. Frits van Rhee, Principal Investigator, University of Arkansas

Sirolimus is a medication that blocks a cell signaling pathway called m-TOR. This drug was originally created to prevent organ rejection in people who had received kidney transplants, and sirolimus became FDA-approved for this use in 1999. Sirolimus is taken orally as a pill and is not an IV medication.

While siltuximab is the only FDA-approved drug for Castleman disease, the first study showing that sirolimus may benefit patients with Castleman disease was published in August 2019. The study included three patients with idiopathic mulitcentric Castleman disease (iMCD) in whom siltuximab had not worked, and the result showed that taking sirolimus had put each of these patients into remission. Read the full text of this published paper here.

I still have questions. Where can I find answers?

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

Share information with others

Share this clinical trial information with others by downloading the clinical trial flier here.

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