A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• Adult participants greater than (>) 18 years of age

• Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment

• No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)

• Verified complete or partial remission after first-line induction therapy including rituximab

Exclusion Criteria:

• Grade 3b follicular lymphoma

• Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma

• Presence of central nervous system lymphoma

• Acquired immunodeficiency syndrome-related lymphoma

• Other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (>=) 5 years