Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)
RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, work in
different ways to stop the growth of cancer cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer
cells.
PURPOSE: This phase II trial is studying how well giving bendamustine together with
mitoxantrone works in treating patients with relapsed or refractory B-cell chronic
lymphocytic leukemia.
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.
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