Sirolimus in Previously Treated Idiopathic Multicentric Castleman Disease
United States7 participantsStarted 2019-09-25
Plain-language summary
The purpose of this study is to understand the impact of sirolimus on idiopathic multicentric Castleman disease.
Who can participate
Age range2 Years – 80 Years
SexALL
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Inclusion Criteria:
* Male or female, age 2-80
* Documented disease history consistent with the diagnostic criteria for iMCD
* Failed/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 as at least two abnormalities in the criteria comprising the CBR criteria, including at least one objective measurement (hemoglobin, weight loss, or lymph node size)
* Ability to consume oral medication in the form of a tablet
* Ability to provide, or for a legally authorized representative to provide on their behalf, informed consent prior to any study-specific activities
Exclusion Criteria:
* Subjects cannot be pregnant or nursing females
* Except for anti-IL6 blockade therapy (siltuximab or tocilizumab), the last dose of which must be ≥ 14 days prior to enrollment (unless subjects cannot or are unwilling to undergo a 14 day washout period), subjects cannot have received any systemic therapy(ies) intended to treat iMCD other than corticosteroids within 28 days of enrollment
* Subjects cannot have previously received sirolimus monotherapy to treat iMCD
* Subjects cannot have any of the following: ECOG \>3 (or Karnofsky/Lansky score ≤ 60 in children); Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 or creatinine \> 3.0 mg/dL; Absolute neutrophil count…
What they're measuring
1
Percentage of Patients Achieving a Positive Clinical Benefit Response (CBR)