Clinical trial NCT01200758
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2011-02-15; Completion date: 2017-10-31
Enrollment: 410 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:

Arms: arm 1: Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy (as per institutional practice) 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. arm 2: First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
Interventions: intervention 1: Rituximab SC intervention 2: Rituximab IV intervention 3: Cyclophosphamide intervention 4: Doxorubicin intervention 5: Vincristine intervention 6: Prednisone/Prednisolone
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Eight cycles of cyclophosphamide (750 mg/m\^2 IV) administered every 3 weeks. intervention 4: Eight cycles of doxorubicin (50 mg/m\^2 IV) administered every 3 weeks. intervention 5: Eight cycles of doxorubicin (1.4 mg/m\^2 IV) administered every 3 weeks. intervention 6: 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.

Protocol documents: