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Ruxolitinib for Idiopathic Multicentric Castleman Disease

This study is testing a drug called ruxolitinib (also known as Jakafi) for adults with idiopathic Multicentric Castleman Disease (iMCD). This is a rare disorder where the body's immune system overproduces cells, causing symptoms like swollen lymph nodes and organ damage. You might be able to join if your iMCD hasn't improved with other treatments like siltuximab or tocilizumab, or if you can't take those medications. The study aims to see if ruxolitinib helps improve your symptoms and how well your body tolerates it. Researchers will look at how many participants show a positive clinical benefit after 12 months. The study plans to enroll 14 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 14 participants.
What's involved
Participants will take ruxolitinib tablets by mouth every day for one year, as long as it's helping and not causing bad side effects.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is assessed at 12 months, comparing results to the baseline visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07085039

Ruxolitinib in Previously Treated Idiopathic Multicentric Castleman Disease

Recruiting
PHASE2Ages 18–80InterventionalTreatment
University of Pennsylvania
~14 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Ruxolitinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 12 months ± 1 month

Conditions

Castleman's Disease (CD)
Idiopathic Multicentric Castleman's Disease

Explore related trials

Multicentric Castleman Disease

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Joshua Brandstadter, MD, PhD, MSc · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Bridget Austin, MS
[email protected]
267-586-9977
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Exclusion

Fungal disease must be stable for at least two weeks before enrollment
Subjects with history of recent bacteremia must have a documented negative blood culture before enrollment
Subjects with past history of non-therapy related opportunistic infection should discuss eligibility and possible immunologic evaluation with the licensed site investigator prior to enrollment 5. Subjects cannot have:
ECOG \>3
eGFR \<30mL/min/1.73 m2 or creatinine \>3.0 mg/dL
Absolute neutrophil count (ANC) \< 1000 x 109/L
Hemoglobin ≤ 6.5 g/dL (transfusion independent, defined as not receiving a red blood cell transfusion for ≥ 7 days prior)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory values greater than three times the upper limit of normal
Albumin \< 2 g/dL (transfusion independent, defined as not receiving intravenous albumin for ≥ 7 days prior)
Platelet count ≤ 40 x 109/L (transfusion independent, defined as not receiving platelet transfusion for ≥ 7 days prior)
Pulmonary involvement or interstitial pneumonitis with dyspnea (adequate pulmonary function is defined as pulse oximetry \> 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest, history of interstitial pneumonitis, etc.)
Fasting cholesterol \> 300 mg/dL or fasting triglyceride \> 400 mg/dL 6. Subjects cannot have rheumatologic disease(s) that is/are exclusionary for / mimickers of iMCD 7. 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
A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antigen (HBsAb) positive and hepatitis B core antibody (HBcAb) negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion.
Subjects with an indolent chronic hepatitis B infection (normal ALT, AST, albumin and no radiographic or biopsy evidence of cirrhosis) may be eligible.
Subjects with active hepatitis C are excluded. Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). 10. Subjects cannot have had any major adverse cardiac events, including ischemic stroke and myocardial infarction, within 6 months of enrollment 11. Subjects cannot have ongoing or planned participation in another clinical trial involving iMCD directed treatment or that involves immunomodulatory or anti-neoplastic treatment 12. Subjects cannot have prior sensitivity / allergy to any formulation of ruxolitinib, its components, or its analogues 13. Subjects cannot have serious medical illness, or psychiatric illness or disorders that could potentially interfere with the completion of treatment according to this protocol or participation in the trial 14. Subjects cannot have psychiatric disorders that compromise their ability to provide informed consent 15. Subjects cannot have any other condition or finding that, in the opinion of the investigator, would make participation in this trial inappropriate

What this trial measures

  • 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 visit12 months ± 1 month

    Clinical Benefit Response (CBR):CBR is defined by improvements in clinical symptoms (fatigue, anorexia, fever and night sweats). Laboratory markers like Hemoglobin levels, weight change and lymph node size are included in the CBR. A CBR is considered positive if there is at least a 25% reduction in the size of the largest lymph node (measured by modified Cheson criteria), a significant improvement in at least one laboratory marker (e.g., hemoglobin), and improvement in at least one clinical symptom without worsening of others. Positive response: Relative to baseline, improvement in at least one of the criterion without worsening of any single criterion other than hemoglobin on two consecutive study visits. Negative response: Relative to baseline, worsening of any single criterion other than hemoglobin on two consecutive site visits or failure to achieve improvement for any criterion.