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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

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.