Ruxolitinib in Previously Treated Idiopathic Multicentric Castleman Disease
United States14 participantsStarted 2025-12-18
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female, age 18-80
✓. Documented disease history consistent with diagnostic criteria for iMCD
✓. 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
Exclusion criteria
✕. Subjects cannot be pregnant or nursing females
✕. Subjects cannot have received any systemic therapy(ies) intended to treat iMCD other than corticosteroids or anti-IL-6 therapy within 14 days of enrollment
✕. Subjects cannot have previously received ruxolitinib monotherapy or combination therapy to treat iMCD
✕. Subjects cannot have uncontrolled infection or infectious disease(s) that is/are exclusionary for / mimickers of iMCD
✕
What they're measuring
1
The proportion of participants achieving a positive Clinical Benefit Response (CBR) response at 12 months ± 1 month. Assessments at 12 months ± 1 month. will be compared to those at the baseline visit
✕. Subjects cannot have rheumatologic disease(s) that is/are exclusionary for / mimickers of iMCD
✕. Subjects cannot have a prior malignancy except for: (1) adequately treated basal cell or squamous cell skin cancer, (2) in situ cervical cancer, or (3) other cancer for which the subject has not received treatment within one year prior to enrollment
✕. Subjects cannot have a documented history of human immunodeficiency virus (HIV) or HHV-8 infection, or severe combined immunodeficiency syndrome