Trial Information

AML2003 - Randomized Comparison Between Standard-Therapy and Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years. A Prospective, Randomized, Multi-center Therapy-Optimizing-Study.

AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem
cell transplantation in aplasia after induction therapy for high risk patients with acute
myeloid leukemia. A rapid analysis of risk-factors (cytogenetics, FLT3 status, clearance of
blasts after first induction) and the donor situation is of utmost importance. For this
"fast search" diagnostic, which is accomplished in all enclosed patients, significant
resources are provided, to take the load off the participating centers. Furthermore, the
relevance of autologous transplantation and the benefit of additional substances within the
postremission therapy such as m-AMSA or mitoxantrone will be investigated. There is an
up-front randomisation in four therapy arms with two cross-classifying factors of two stages
(intensified vs. standard therapy and Ara C vs. Ara C+ mitoxantrone + m-AMSA). Thus, the
intergroup treatment schedule of the German Competence Network is integrated into the
AML2003 study as a central element and 25% of the patients are treated accordingly. In the
intensified therapy arms a risk-adapted and priority-based therapy is implemented, including
early allogeneic and consolidating autologous stem cell transplantation, respectively. In
addition to the clinical questions , a detailed concomitant research program was initiated
for the AML2003 study, to get a better view of the heterogeneity of AML and to open new ways
for "custom-made" therapies.