MedTrace Logo

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

NCT00930514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2016-11-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00930514 on ClinicalTrials.gov