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

Roche

Status and phase: Completed; Phase 4

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: rituximab [MabThera/Rituxan]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430352

MO19872

Details and patient eligibility

About

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.

Enrollment: 545 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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545 participants in 1 patient group

1

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]