relapsed CLL: Does adding lumiliximab improve on FCR?

February 16, 2011

" Thirty-one patients gave consent and were treated at 5 clinical sites.

The median age was 58 years with 8 patients being at least 65 years old. The

majority of patients (71%) had Rai stage I/II disease, and the median â-2

microglobulin level was 3.3 ìg/mL.

The median number of therapies was 2, with 61% of patients having received

fludarabine. Three subjects were refractory to fludarabine, as defined by

failure to achieve a complete or partial response of at least 6 months

duration after their last fludarabine-containing treatment regimen. "

" This is the first study of lumiliximab in combination with FCR in patients

with relapsed or refractory CLL. Treatment with lumiliximab combined with

FCR was well tolerated, resulted in a high number of patients with a durable

CR, and was not associated with increased infectious risk or prolonged

cytopenias compared with historical controls. "

..

" Although comparison with a historical control phase 2 trial of FCR has

significant limitations, it is notable that the CR rate of 52% observed in

this trial is double that of a large reported single institution trial by

Wierda and colleagues14 in which 25% exhibited a CR. ORR was not

significantly different in these 2 trials. "

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