AML-BFM 2004

The AML-BFM 2004 trial is an multicenter dose-optimization trial for the treatment of acute myeloid leukeamias in children and adolescents. Patients are treatetd with a combination of intensive chemotherapy in combination with a radiation of the central nervous system (stopped with the amendment of April 2010) and /or haematopoietic stem cell transplantation.
The patients are stratified in a standard-group (SR) and a high risk-group (HR).

All randomizations are closed in April 2010. The trial is prolonged untill March 2011.
In the SR-Arm all patients receive liposomal daunorubicin. In the HR-Arm all patients receive 2-CDA as intensification during the consolidation course.
The prophylactic radiation of the central nervous system is stopped. The Investigator recommends the implementation of Triple-intrathecal injections.

• Age from 0 to 18 years
• De novo AML, incl. children with Down’s syndrome, primary myelosarcomas or acute mixed lineage leukeamia / biphenotypic leukeamia (predominantly myeloid)
• Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004

• Children with pre-existing syndromes (except Down’s syndrome)
• AML as secondary malignancy
• Accompanying diseases which do not allow therapy according to the protocol
• Pre-treatment for more than 14 days with another intensive induction therapy