Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20⁺ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study.

ABSTRACT: This multicenter, randomized, double-blind, parallel-controlled trial aimed to compare the pharmacokinetics (PK) of IBI301 with rituximab in patients with CD20-positive (CD20⁺) B-cell lymphoma, who achieved a complete response/unconfirmed complete response after standard treatments. Patients were randomized (1:1) to receive IBI301 or rituximab (375 mg/m², IV). Patients who continuously benefitted from the trial after the PK phase underwent the extension phase to receive up to three cycles of 3-month-cycle of rituximab/IBI301 maintenance therapy. PK was described using the area under the serum concentration-time curve from time zero to infinity (AUC_0-inf), AUC from time zero to last quantifiable concentration (AUC_0-t), and maximum serum concentrat

SUBMITTER: Jiang B 

PROVIDER: S-EPMC7363910 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature