Randomized Comparison of Sequential High-Dose Cytosine Arabinoside and Idarubicin (S-HAI) with or without Chemo-Modulation by Fludarabine in Refractory and Relapsed Acute Myeloid Leukemia

In order to assess the value of the addition of fludarabine as a chemo-modulator to a high-dose AraC based salvage regimen for patients with refractory and relapsed acute myeloid leukemia the German AML Cooperative Group initiated a prospective randomized comparison between fludarabine q 12 hours on days 1,2,8, and 9 in addition to the S-HAI regimen, consisting of high-dose AraC q 12 hours on days 1, 2, 8, and 9 and idarubicin on days 3,4,10, and 11, as compared with S-HAI alone. Ninety-one patients have entered the ongoing study, 66 of whom are fully evaluable at the present time (median age 54 years, range 20-75). Twentyfive patients had refractory disease or early relapses, 39 patients h…