A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
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.
Inclusion Criteria:
Exclusion Criteria:
Banja Luka, 88000, Bosnia and Herzegovina
Tuzla, 75000, Bosnia and Herzegovina
Belo Horizonte, Minas Gerais 30140-001, Brazil
São Paulo, São Paulo 01221-020, Brazil
Québec, G1J 1Z4, Canada
Medellin-Antioquia, Colombia
Dresden, 01307, Germany
Giessen, 35392, Germany
Greifswald, 17475, Germany
Halle, 06110, Germany
Hanover, 30625, Germany
Olpe, 57462, Germany
San Giovanni Rotondo, Apulia 71013, Italy
Naples, Campania 80131, Italy
Reggio Emilia, Emilia-Romagna 42100, Italy
Kuala Lumpur, FED. Territory of Kuala Lumpur 59100, Malaysia
Sarawak, Sarawak 93586, Malaysia
Chihuahua City, 31000, Mexico
Târgu Mureş, 540136, Romania
Moscow, 115478, Russia
Saint Petersburg, 197022, Russia
St.Petersburg, Pesochny, 197758, Russia
Singapore, 119228, Singapore
Johannesburg, 2193, South Africa
Istanbul, 34098, Turkey (Türkiye)