NCT00930514

A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma

A Two Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Rituximab Subcutaneous (SC) Formulation in Patients With Follicular Lymphoma (FL) as Part of Maintenance Treatment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
DRUG	Rituximab	Rituximab subcutaneous injection at 800 mg/m\^2 dose level, administered every 2 or 3 months.
DRUG	Rituximab	Rituximab subcutaneous injection 625 mg/m\^2 administered every 2 or 3 months.
DRUG	Rituximab	Rituximab intravenous infusion 375 milligram per square meter (mg/m\^2) administered every 2 or 3 months.
DRUG	Rituximab	Rituximab subcutaneous injection 375 mg/m\^2 administered every 2 or 3 months.

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2009-06-30
• Last updated: 2016-11-02

Locations

62 sites across 22 countries: Argentina, Australia, Brazil, Canada, Czechia, Denmark, Ecuador, Finland, France, Israel, Italy, Mexico, Norway, Peru, Poland, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, United Kingdom