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

2014-08-27 03:12:54 | BioPortfolio

Summary

This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in patients with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Patients will receive MabThera (372 mg/m2 intravenously) on day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In patients experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles. Anticipated time on study treatment is 6 to 8 months.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lymphoma, B-Cell

Intervention

rituximab [Mabthera/Rituxan], fludarabine, cyclophosphamide, mitoxantrone

Status

Not yet recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:54-0400

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