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

Roche

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Follicular

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00930514

2008-008490-60

BP22333

Details and patient eligibility

About

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.

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CD20-positive follicular non-Hodgkin's lymphoma (NHL)
• Documented partial or complete response a the end of induction treatment with rituximab
• Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (<=) 2
• Life expectancy of greater than and equal to (>=) 6 months

Exclusion criteria

• Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma
• Presence or history of central nervous system disease
• History of malignancy other than follicular NHL
• Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy

Trial design

281 participants in 6 patient groups

Rituximab IV 375 mg/m^2 (Stage 1: Cohort A)

Active Comparator group

Treatment:

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Rituximab IV 375 mg/m^2 (Stage 2: Cohort E)

Active Comparator group

Treatment:

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Rituximab SC 1400 mg (Stage 2: Cohort F)

Experimental group

Treatment:

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Rituximab SC 375 mg/m^2 (Stage 1: Cohort B)

Experimental group

Treatment:

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Rituximab SC 625 mg/m^2 (Stage 1: Cohort C)

Experimental group

Treatment:

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Rituximab SC 800 mg/m^2 (Stage 1: Cohort D)

Experimental group

Treatment:

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab

Drug: Rituximab