A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Trial end date: 2011-07-21
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, 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 60-75 years of age;

• B-cell follicular NHL;

• no previous treatment;

• active disease, with rapid progression.

Exclusion Criteria:

• other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;

• long-term use (>1 month) of systemic corticosteroids;

• central nervous system involvement;

• history of significant cardiovascular disease;

• positive test result for HIV, or hepatitis B or C.