Recruitment In A Randomized, Double-Blind, Placebo-Controlled Study To Assess Siltuximab (Cnto 328), An Anti-Il-6 Monoclonal Antibody, In Patients With Multicentric Castleman'S Disease.
JOURNAL OF CLINICAL ONCOLOGY(2012)
摘要
TPS8117 Background: Multicentric Castleman’s disease (MCD) is a rare lymphoproliferative disorder in which dysregulated production of interleukin (IL)-6 results in lymph node enlargement and debilitating symptoms, including systemic inflammatory manifestations (eg, fever, fatigue, weight loss), autoimmune phenomena, and markedly abnormal laboratory findings (eg, anemia, hyper-γ-globulinemia, hypoalbuminemia, thrombocytosis, increases in acute-phase proteins such as CRP, ESR, fibrinogen). There is currently no approved systemic treatment for MCD in the US or EU. Siltuximab (CNTO 328) is a chimeric mAb with high affinity for soluble IL-6. In a previous phase 1 study, high objective tumor response rate (64%) has been observed in patients with MCD (van Rhee F et al. Blood 2008;112:1008), and the long-term safety profile looks favourable (Kurzrock R et al. Blood 2011;118:3959). These results have prompted a randomized, double-blind, placebo-controlled study to definitively assess the efficacy and safety of sil...
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