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Clinical Question: Does bendamustine effective in
treating relapsed or refractory type of Chronic Lymphocytic Leukemia?
Bottom Line: The study confirms the excellent efficacy of
bendamustine in heavily pre-treated and treatment-refractory patients, even
at reduced doses of 140 mg/m2 per course. In pre-treated CLL patients,
impaired bone marrow function is likely to enhance the myelotoxic side
effects of bendamustine. Based on these results, the recommended optimal
therapeutic dose of bendamustine in refractory CLL is 70 mg/m2 on days 1 and
2 every 4 weeks.
Reference: Haematologica. 2005 Oct;90(10):1357-64.Efficacy of
bendamustine in patients with relapsed or refractory chronic lymphocytic
leukemia: results of a phase I/II study of the German CLL Study Group.
Bergmann MA, Goebeler ME, Herold M, Emmerich B, Wilhelm M, Ruelfs C, Boening
L, Hallek MJ; German CLL Study Group.
Synopsis: Although bendamustine has been used for more than
30 years in the treatment of lymphoma, little is known about the optimal
dosing schedule in relapsed or refractory B-cell chronic lymphocytic
leukemia (CLL). Various dose and treatment schedules have been used
empirically, and several phase II studies have shown impressive efficacy. To
determine the maximal tolerated dose, dose-limiting toxicity and the optimal
therapeutic dose of bendamustine for further phase III clinical trials the
GCLLSG designed a phase I/II study for pre-treated CLL patients.
Sixteen patients (median age 67 years) with relapsed or refractory CLL were
enrolled. All patients had been pre-treated with a median of three different
regimens. Bendamustine was given at a starting dose of 100 mg/m2 on day 1
and 2, repeated every 3-4 weeks. RESULTS: Major toxicities were
leukocytopenia (CTC grade 3+4) in 8/16 and infections (CTC grade 3+4) in
7/16 patients. Six patients had dose-limiting toxicity which led to dose
de-escalation from 100 to 70 mg/m2 in three patients. The maximum tolerated
dose was 70 mg/m2. According to NCI-WG criteria, 9/16 patients (56%)
responded to therapy, seven to doses
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