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

Sponsor
Hoffmann-La Roche
Study ID
NCT00930514
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, Follicular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2009
Status verified
Nov 2016
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
281 participants (actual)
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab IV 375 mg/m^2 (Stage 1: Cohort A)
  • Active Comparator: Rituximab IV 375 mg/m^2 (Stage 2: Cohort E)
  • Experimental: Rituximab SC 1400 mg (Stage 2: Cohort F)
  • Experimental: Rituximab SC 375 mg/m^2 (Stage 1: Cohort B)
  • Experimental: Rituximab SC 625 mg/m^2 (Stage 1: Cohort C)
  • Experimental: Rituximab SC 800 mg/m^2 (Stage 1: Cohort D)

Primary Outcome Measure

Minimum Observed Plasma Trough Concentration (C trough) [ Time Frame: Up to 29 months ]

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