A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma

A Randomized, Open-label Study of the Effect of MabThera Plus Chemotherapy Versus Chemotherapy Alone on Clinical Response in Patients With Indolent Non-Hodgkin's and Mantle Cell Lymphoma

This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients >=18 years of age;
• advanced, low-grade non-Hodgkin's and mantle cell lymphoma.

Exclusion Criteria:

• possibility of curative radiation therapy;
• secondary NHL;
• participation in another clinical trial eg with cytostatic chemotherapy or cytokines;
• concomitant diseases and/or restricted organ function precluding therapy according to the study protocol.