Conditions: Diffuse Large B-Cell Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m\^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.

Detailed description:

Arms:
arm 1: Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).

Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Mitoxantrone intervention 4: Rituximab
Intervention descriptions: intervention 1: as prescribed, 6 cycles intervention 2: as prescribed, 6 cycles intervention 3: as prescribed, 6 cycles intervention 4: 375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles

Protocol document: