A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma

This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• histologically-proven mantle cell lymphoma;
• previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria:

• known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
• active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
• serious disorders interfering with full standard dosing chemotherapy;
• stage I disease.