A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma

Summary

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

DRUG

Rituximab SC

First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.

DRUG

Rituximab IV

Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.

DRUG

Cyclophosphamide

Eight cycles of cyclophosphamide (750 mg/m\^2 IV) administered every 3 weeks.

DRUG

Doxorubicin

Eight cycles of doxorubicin (50 mg/m\^2 IV) administered every 3 weeks.

DRUG

Vincristine

Eight cycles of doxorubicin (1.4 mg/m\^2 IV) administered every 3 weeks.

DRUG

Prednisone/Prednisolone

Eight cycles of prednisone/prednisolone (100 mg/day or 40 mg/m\^2/day IV/orally) administered Days 1 to 5 of every 21 days cycle.

Sponsors & Collaborators

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-15

Primary Completion

2012-06-12

Completion

2017-10-31

Countries

• Australia
• Belgium
• Bosnia and Herzegovina
• Brazil
• Bulgaria
• Canada
• Colombia
• Croatia
• Denmark
• Finland
• France
• Georgia
• Germany
• Greece
• Italy
• Malaysia
• Mexico
• New Zealand
• North Macedonia
• Peru
• Romania
• Russia
• Serbia
• Singapore
• Slovakia
• South Africa
• Spain
• Thailand
• Turkey (Türkiye)
• United Kingdom

Study Locations