- Objectives
- Primary objective: To evaluate in patients with advanced follicular lymphoma the
benefit of maintenance therapy with rituximab after induction of response with
chemotherapy plus rituximab in comparison with no maintenance therapy
- Secondary objective: To evaluate response rates, event driven survival endpoints
(EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined
with rituximab, with or without maintenance with rituximab, for first line
treatment of advanced stage follicular lymphoma.
- Study Design This is an international open-label, multicentre, randomized study with two
treatment phases. In the induction phase patients have to respond to 1st line induction
treatment in order to be eligible for randomization to the second phase of maintenance
treatment or observation. After the maintenance period patients will be included in the
follow up phase for 3 years.
Phase:
Phase 3
Details
Lead Sponsor:
Lymphoma Study Association
Collaborators:
Australasian Leukaemia and Lymphoma Group German Low Grade Lymphoma Study Group HOVON - Dutch Haemato-Oncology Association Institute of Cancer Research, United Kingdom OSHO