Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

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

SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.

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)