Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia (original) (raw)

British journal of clinical pharmacology, 2015

Abstract

The aim of the phase Ib, two-part SAWYER study (BO25341; NCT01292603) was to investigate the pharmacokinetics and safety of subcutaneous (SC) rituximab compared with intravenous (IV) rituximab, both in combination with fludarabine and cyclophosphamide (FC), as first-line treatment for patients with chronic lymphocytic leukaemia (CLL). During Part 1 (dose-finding), CLL patients received rituximab IV followed by a single dose of rituximab SC at one of three fixed doses (1400, 1600 or 1870 mg) in cycle 6. The primary objective was to identify a fixed SC dose that would achieve comparable rituximab serum trough concentrations (Ctrough ) to those achieved with the standard 4-weekly 500 mg/m(2) rituximab IV dose. Fifty-five patients received a fixed dose of rituximab SC; 16 received 1400 mg, 17 received 1600 mg and 22 received 1870 mg. The 1600 mg dose was predicted to achieve non-inferior Ctrough to standard rituximab IV treatment. The rituximab SC safety profile was comparable to rituxi...

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