A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment versus Observation alone in Patients with Aggressive B-cell lymphoma:

INTERVENTION: Trade Name: MabThera Product Code: RO 45‐2294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg milligram(s) Trade Name: MabThera Product Name: MabThera Product Code: RO 45‐2294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg milligram(s) CONDITION: Aggressive Non Hodgkin´s Lymphoma (NHL) PRIMARY OUTCOME: Main Objective: Primary objective:; To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B‐cell Non‐Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first‐line therapy, measured by event‐free survival (EFS) ; Primary end point(s): Event‐free survival (EFS) defined as the time from randomization to progression, relapse, death from any cause, or instituition of new anti‐lymphoma treatment Secondary Objective: Secondary objective: ; To evaluate Progression‐free Survival (PFS), Overall Survival (OS) and Safety. INCLUSION CRITERIA: Patients must have received eight infusions of rituximab plus 4 – 8 cycles of CHOP‐like chemotherapy including an anthracycline Induction treatment must have been completed with the application of the final cycle of chemotherapy or immunotherapy no longer than 12 weeks, and no earlier than 4 weeks before trial treatment start. Patients must have reached a complete remission (CR) or an unconfirmed CR (CRu) after induction therapy Histologic diagnosis of either diffuse large B‐cell lymphoma (DLBCL) or follicular lymphoma grade 3b according to the WHO/REAL classification at time of diagnosis (prior to induction therapy) Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy) ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV ) Known IPI at time of diagnosis (prior to induction therapy) Age 18 years or older Life expectancy of at least 3 months