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The value of high dose versus standard dose Ara-c during induction and IL-2 after intensive consolidation/autologous stem cell transplantation in patients (age 15-60 yrs) with acute myelogenous leukemia. A randomized phase III trial of the EORTC and GIMEMA Leukemia Cooperative Groups (AML-12).

Study documentation

Trial Status All trial activities ended
Dates Date of activation: 03-Sep-1999
Date Step1 close: 11-Jan-2008
Date Step2 close: 30-Jun-2008
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 1000 - All Groups: 2000
Treatment Cytarabine, Daunorubicin, Etoposide, Filgrastim, Aldesleukin, Lenograstim
Study Staff
Type of cancer
Participating groups EORTC Leukemia Group
Gruppo Italiano Malattie Ematologiche dell'Adulto
Protocol summary
NCT number NCT00004128