AIMS:

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).

METHODS:

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/m2 rituximab IV dose.

 

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