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:
Participant gender:
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.