A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and
intravenous rituximab in participants with follicular lymphoma. In the first stage,
participants who have achieved at least a partial response after induction treatment with
intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab
375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625
mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of
the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C
trough) values comparable to those achieved with the intravenous formulation, participants in
the second stage of the study will be randomized to receive either the subcutaneous or
intravenous formulation to demonstrate comparability of the C trough levels with both routes
of administration. Maintenance therapy will continue every 2 or 3 months with the
subcutaneous formulation.