IDARUBICIN AND CYTOSINE-ARABINOSIDE REINDUCTION THERAPY FOR CHILDREN WITH MULTIPLE RECURRENT OR REFRACTORY ACUTE LYMPHOBLASTIC-LEUKEMIA - APEDIATRIC-ONCOLOGY-GROUP STUDY

Purpose: This study was designed to determine the toxicity of and resp onse to idarubicin and cytosine arabinoside in children and adolescent s with acute lymphoblastic leukemia (ALL) who had refractory or recurr ent bone marrow disease.Patients and Methods: Patients <21 years of ag e with ALL in second or later bone marrow relapse or refractory to ind uction therapy were eligible. Some patients also had concurrent centra l nervous system (CNS) relapse. Therapy consisted of cytosine arabinos ide, 1 g/m(2)/day given as a 6-h infusion, followed by bolus idarubici n, 5 mg/m(2)/day, both daily for 6 days. Children achieving remission received maintenance therapy with 3 days of etoposide, 100 mg/m(2)/day , followed by ifosfamide, 2.8 g/m(2)/day, alternating every 3 weeks wi th 3 days of cytosine arabinoside and idarubicin in the dosages descri bed earlier. All courses of therapy were followed by granulocyte colon y-stimulating factor (G-CSF). Removal from study to undergo bone marro w transplantation (BMT) was encouraged. Results: Eighty-two patients w ere entered. There were 14 deaths (nine early), mostly from documented or presumed bacterial or fungal sepsis. Overall, 30 patients achieved complete remission (37%). These were mostly of brief duration - only one patient was still alive at 600+ days after BMT. Conclusions: Cytos ine arabinoside and idarubicin showed moderate activity in heavily pre treated children with ALL.