Safety, Pharmacokinetics, and Preliminary Clinical Activity of Inotuzumab Ozogamicin, a Novel Immunoconjugate for the Treatment of B-Cell Non-Hodgkin's Lymphoma: Results of a Phase I Study
作者： Anjali Advani , Bertrand Coiffier , Myron S. Czuczman , Martin Dreyling , James Foran
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摘要: Purpose Inotuzumab ozogamicin (CMC-544) is an antibody-targeted chemotherapy agent composed of a humanized anti-CD22 antibody conjugated to calicheamicin, potent cytotoxic agent. This was phase I study determine the maximum-tolerated dose (MTD), safety, and preliminary efficacy inotuzumab in expanded MTD cohort patients with relapsed or refractory CD22+ B-cell non-Hodgkin's lymphoma (NHL). Patients Methods administered intravenously as single once every 3 4 weeks at doses ranging from 0.4 2.4 mg/m2. Outcomes included MTD, pharmacokinetics, response, progression-free survival (PFS), overall survival. Results Seventy-nine were enrolled. The determined be 1.8 Common adverse events thrombocytopenia (90%), asthenia (67%), nausea neutropenia (51% each). objective response rate end treatment 39% for 79 enrolled patients, 68% all follicular N...
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