Trial Information

Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)

OBJECTIVES:

Primary

- Determine the response rate (remission rate) in patients with relapsed or refractory
B-cell chronic lymphocytic leukemia (CLL) treated with bendamustine and mitoxantrone
hydrochloride.

Secondary

- Determine the progression-free survival and overall survival of patients treated with
this regimen.

- Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive bendamustine IV over 1 hour on days1-3 and mitoxantrone hydrochloride IV
over 30 minutes on day 1. Treatment repeats every 28 days for at least 2 courses in the
absence of disease progression or unacceptable toxicity. Patients with responding disease
(i.e., complete response or partial response) after 2 courses receive 2 additional courses
of treatment for a total of 4 courses.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total 60 patients will be accrued for this study.