Combination Therapy With Bendamustine and Rituximab Demonstrates Marked Efficacy in Patients With Relapsed/Refractory CLL

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CCO Independent Conference Coverage of the American Society of Hematology 2008

Annual Meeting*

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Combination Therapy With Bendamustine and Rituximab Demonstrates Marked Efficacy

in Patients With Relapsed/Refractory CLL

Posting Date: December 10, 2008

a.. Prospective, multicenter, open-label, nonrandomized, phase II study of the

German CLL Study Group (GCLLSG)[1]

Summary of Key Conclusions

a.. Bendamustine-plus-rituximab combination therapy effective in patients with

relapsed/refractory chronic lymphocytic leukemia (CLL)

a.. Potent activity observed even in patients with high-risk CLL

b.. Major treatment toxicity included myelosuppression and infection

a.. Adverse events generally manageable

c.. Ongoing follow-up seeking to define response duration and long-term safety

d.. In upcoming GCLLSG study, bendamustine + rituximab will be compared with

fludarabine + cyclophosphamide + rituximab as first-line treatment for CLL

Background

a.. Bendamustine

a.. Alkylating agent with additional properties of a purine analogue

b.. Substantial activity as monotherapy in patients with CLL

c.. In vitro, bendamustine and rituximab have synergistic proapoptotic

activity in primary CLL cells

d.. Clinical activity with bendamustine and rituximab observed in patients

with relapsed/refractory[2] and previously untreated non-Hodgkin's lymphoma[3]

b.. Current study evaluated efficacy and toxicity of

bendamustine-plus-rituximab regimen in patients with relapsed/refractory CLL

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