Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease
Stopped: Internal Company Decision
United States22 participantsStarted 2021-03-31
Plain-language summary
Phase 2 study to investigate the safety, tolerability, and efficacy of administering increased siltuximab doses to patients with iMCD
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented history of consensus histologic, laboratory, and clinical diagnostic criteria of iMCD.
* Archival and/or baseline incisional/excisional biopsy for retrospective central histologic confirmation of iMCD.
* CDCNRC-defined disease progression on or after prior treatment with siltuximab at 11 mg/kg q3w without unacceptable toxicity within 12 weeks between the last dose of siltuximab and the date of signed patient informed consent form (ICF).
* At least 1 measurable abnormal lymph node mass that is ≥1 cm in its longest transverse diameter as assessed by computerized tomography (CT) scan that has not been previously irradiated.
* Elevated (\>10 mg/L) and rising serum CRP in the absence of additional iMCD treatment.
* Evidence of at least an additional one of the following laboratory or clinical signs of iMCD per international, evidence-based consensus diagnostic criteria for HIV or HHV 8-negative iMCD:
* Anemia, thrombocytopenia, hypoalbuminemia, renal dysfunction, or polyclonal hypergammaglobulinemia.
* Constitutional symptoms (night sweats, fever (\>38°C), weight loss, or fatigue (CTCAE lymphoma B-symptoms score ≥2), large spleen and/or liver, fluid accumulation, eruptive cherry hemangiomatosis/violaceous papules, or lymphocytic interstitial pneumonitis.
* Adequate clinical laboratory measurements within 3 weeks prior to study entry in all parameters below:
* Absolute neutrophil count ≥1.0 × 109/L, hemoglobin \<17 g/dL, and platelets ≥50 ×…
What they're measuring
1
Assess the Clinical Benefit Response (CBR) of Siltuximab