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Sponsor: Hoffmann-La Roche
Conditions: Non-Hodgkin's Lymphoma
Interventions: Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine
Countries: Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry with material available for central review * No prior treatment * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: * Grade 3b follicular lymphoma * Transformation to high-grade lymphoma secondary to follicular lymphoma * Types of Non-Hodgkin's lymphoma other than follicular lymphoma * Presence or history of central nervous system (CNS) disease * Corticoid therapy during the last 4 weeks, except prednisone treatment less than (\<) 20 milligrams per day (mg per day) * Known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication
- Gosford, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Herston, Queensland, Australia
- Southport, Queensland, Australia
- Woodville South, South Australia, Australia
- Edegem, Belgium
- Liège, Belgium
- Wilrijk, Belgium
- Banja Luka, Bosnia and Herzegovina
- Sarajevo, Bosnia and Herzegovina
- Tuzla, Bosnia and Herzegovina
- Belo Horizonte, Minas Gerais, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Pleven, Bulgaria
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Varna, Bulgaria
- Halifax, Nova Scotia, Canada
- Laval, Quebec, Canada
- Rimouski, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Trois-Rivières, Quebec, Canada
- Québec, Canada
- Bogotá, Colombia
- Cali, Colombia
- Medellin-Antioquia, Colombia
- Pereira, Colombia
- + 122 more on CT.gov