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Clofarabine (40 mg/m(2)/day × 5) and high-dose cytosine arabinoside (Ara-C, 1-2 g/m(2)/day × 5) were used in 10 men and 11 women, at a median age of 45 (22-62) years, with refractory (N = 4) and relapsed (N = 17) acute myeloid leukaemia, after a median of 3 (2-5) prior regimens. Grade 4 myelosuppression was observed in all cases, with two patients dying of bacterial sepsis. Nine patients achieved a complete remission. Disease status, number of prior therapies, and cytogenetic aberrations were not associated with the outcome. However, remission was only achieved with Ara-C at 2 g/m(2)/day and not 1 g/m(2)/day (9/15 versus 0/4, P = 0.03).

Clofarabine and high-dose cytosine arabinoside in the treatment of refractory or relapsed acute myeloid leukaemia