A Phase II, Single-Arm Open-Label Multi-Center Study of Ruxolitinib in Previously Treated Idiopathic Multicentric Castleman Disease
University of Pennsylvania
Summary
The research study is being done to look at the effects of ruxolitinib in adults with idiopathic Multicentric Castleman Disease (iMCD) that has not gotten better from taking siltuximab or tocilizumab, or who cannot take those medications.
Description
There is currently no agreed-on recommended treatment for iMCD patients whose disease does not respond to siltuximab or tocilizumab, which is a major challenge for patients. The purpose of this study is to find out the effects of a study drug, ruxolitinib (also called Jakafi), in these patients. This study looks at how well the drug is tolerated by participants and its effects on participants' iMCD symptoms.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female, age 18-80 2. Documented disease history consistent with diagnostic criteria for iMCD • Indication of clinico-histopathological features consistent with iMCD as determined by a licensed pathologist in a diagnostic pathology report, or a CAS grade of at least 3 in the companion registry study (ACCELERATE). 3. Refractory (patient did not achieve sufficient disease control with anti-IL-6 therapy, as determined by the site investigator), relapsed (return of symptoms while on therapy), or inability to tolerate anti-IL-6 or anti-IL-6 receptor therapy 4. Evi…
Interventions
- DrugRuxolitinib
Participants will take the study drug in a tablet form, by mouth, every day for the next year, as long as it is helping with their disease and not causing unacceptable side effects.
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania