Phase-II trial of idarubicin, fludarabine, cytosine arabinoside, and filgrastim (Ida-FLAG) for treatment of refractory, relapsed, and secondary AML

The current phase-IT trial was initiated to assess the efficacy and toxicit y of the Ida-ELAG regimen in patients with poor-risk acute myeloid leukemia (AML). Three subgroups of patients with AML were eligible for the study: ( a) refractory, (b) first: relapse, or (c) secondary AML (i.e., signs of tri lineage myelodysplasia at diagnosis or the history of a myelodysplasia or m yeloproliferative disorder). Fifty-seven fully evaluable patients were incl uded in the study. Twenty patients received a second course of Ida-FLAG. Co mplete remission was achieved by 1/14 patients with refractory AML, 12/15 p atients with relapsed AML, and 17/28 patients with secondary AML. The media n duration of ANC <1000/mu l was 17 days (10-36); of platelets < 30,000/mu l 23 days (9-65); of days with fever >38.0 degrees C 6 days (1-33). Thirtee n patients (22.8%) died within 42 days of severe infection or hemorrhage. O verall survival at 20 weeks in the subgroups was 24% for patients with refr actory, 78% for patients with relapsed, and 55% for patients with secondary AML. The toxicity of the first cycle of Ida-FLAG is moderate, The feasibil ity and subjective tolerance of the Ida-FLAG regimen are acceptable. There is no evidence for an increase of atypical infections. The efficacy for pat ients with secondary AML and especially those with first relapse of AML is good, with a high rate of complete remissions. Remission duration seems to be short. Therefore, an intensified post-remission therapy seems necessary.