Conditions: Lymphoma, Large B-Cell, Diffuse
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 572
Healthy volunteers: no

Brief summary:
This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: CHOP intervention 2: rituximab [MabThera/Rituxan] intervention 3: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles intervention 2: The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles intervention 3: 375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

Protocol document: