MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

• Status: Completed
• Trial end date: 2011-05-26
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;

• patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;

• demonstrated partial or complete response to induction therapy.

Exclusion Criteria:

• stable or progressive disease after most recent induction therapy;

• transformation to high grade lymphoma;

• patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.