A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

Inclusion Criteria

ELIGIBILITY:

Key Inclusion Criteria

- Documented B-cell Non-Hodgkin's Lymphoma

- Small lymphocytic lymphoma (ALC < 5,000 cells/mm3)

- Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)

- Lymphoplasmacytic lymphoma

- Follicular center lymphoma, follicular

Disease documented to be refractory to a full-course of the most recent rituximab therapy
(single agent or combination)

- At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens

- Bidimensionally measurable disease (by CT scan) with at least one lesion measuring ≥
2.0 cm in a single dimension

Key Exclusion Criteria

- Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan
(Zevalin®) will not be eligible

- History of prior high dose chemotherapy with allogeneic stem cell support (history of
autologous stem cell support is permissible)