A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Mitoxantrone; Rituximab

Criteria

Inclusion Criteria:

• adult participants, >/=18 years of age

• untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation

• known mantle cell lymphoma international prognostic index (MIPI) at diagnosis

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• adequate hematological, renal and hepatic function

Exclusion Criteria:

• known hypersensitivity to murine proteins or chemotherapy regimen

• previous first-line therapy

• history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma

• active infection

• clinically significant cardiac disease

• regular corticosteroid treatment in the 4 weeks prior to first dose of study drug