A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia.
Status:
Terminated
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
Summary
In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared
idarubicin or daunorubicin throughout the study (first randomization) and two different
post-remission strategies (second randomization): one single intensive consolidation course
similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin
(day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly
basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence
for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the
post-remission therapy comparison.