Procedures
INFUSION REACTION
In Phase 1, patients received a starting dose of Isa (10 mg/kg) every week in Cycle 1, every 2 weeks in Cycles 2–6, and every 3 weeks thereafter. Cemi was given at 250 mg every 2 weeks in Cycles 1–6, and at 350 mg every 3 weeks thereafter. The cycle duration was 28 days for Cycles 1–6, then 21 days in subsequent cycles. All participants received the following premedications (or equivalent), 30–60 min before Isa infusion, to prevent or reduce the incidence or severity of infusion reactions: oral acetaminophen 650–1000 mg, ranitidine 50 mg intravenously (IV), diphenhydramine 25–50 mg IV, methylprednisolone 100 mg IV, and oral montelukast 10 mg.