A Phase II, Single-Arm Open-Label Multi-Center Study of Ruxolitinib in Previously Treated Idiopathic Multicentric Castleman Disease
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.
• Male or female, age 18-80
• 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).
• 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
• Evidence of active disease, defined by at least two of: constitutional symptoms (fatigue, night sweats, fever, weight change), hemoglobin \< lower limit of normal, C-reactive protein \> upper limit of normal (or \>10 mg/L), or albumin \< lower limit of normal (\<3.5 g/dL), at lease one lymph node meeting modified Cheson criteria
• Ability to consume oral medication in the form of a tablet
• Ability to provide informed consent prior to any study-specific activities