This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
The second course is randomised to either ADxE (standard arm) or FLADx
Minimal residual disease
MRD will be measured by flow cytometry. In the randomisation for course 1 the endpoint is at day 22. In the randomisation for course 2 the endpoint is immediately before start of consolidation
Time frame: On day 22 after the first induction and after second induction
Event-free survival
Event-free survival at five years
Time frame: 5 years
Acute toxicity
Hematological and other organ toxicity after each course
Time frame: six months
Long-term toxicity
Long-term toxicity in particular cardiac toxicity
Time frame: 10 years
Overall survival
Overall survival at five years
Time frame: Five years
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HUDERF, L'Hôpital des Enfants Hématologie / Oncologie
Brussels, Belgium
RECRUITINGUZ Brussel, Pediatrische Hemato-Oncologie F930
Brussels, Belgium
RECRUITINGUCL, Cliniques Universitaires Saint-Luc
Brussels, Belgium
RECRUITINGGhent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology
Ghent, Belgium
RECRUITINGUZ Leuven, Kinder Hemato-Oncologie
Leuven, Belgium
RECRUITINGCHR Citadelle
Liège, Belgium
RECRUITINGCHC Espérance
Montegnée, Belgium
RECRUITINGDepartment of Pediatrics, Aarhus University Hospital Skejby
Aarhus, Denmark
RECRUITINGDept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen
Copenhagen, Denmark
RECRUITINGTallinn Children's Hospital, Dep. Hematology oncology
Tallinn, Estonia
NOT_YET_RECRUITING...and 22 more locations