Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy.

The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborator: Deutsche Krebshilfe e.V., Bonn (Germany)
• Treatments: Cladribine; Daunorubicin; Idarubicin

Criteria

Inclusion Criteria:

• Age from >0 to
• De novo AML, including children with Down syndrome, primary myelosarcomas or acute mixed lineage leukemia/biphenotypic leukemia (predominantly myeloid)

• Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004

Exclusion Criteria:

• Children with pre-existing syndromes (except Down 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