Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
Pediatric Acute Myeloblastic Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Randomisation course 1 mitoxantrone versus DaunoXome Type: Drug
Name: Randomisation course 2 ADxE versus FLADx Type: Drug
Overall Status
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 18 Years
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

1. AML as defined by the WHO diagnostic criteria

2. Age < 19 years at time of diagnosis

3. Written informed consent

Exclusion Criteria:

1. Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy

2. AML secondary to previous bone marrow failure syndrome.

3. Down syndrome (DS)

4. Acute promyelocytic leukaemia (APL)

5. Myelodysplastic syndrome (MDS)

6. Juvenile Myelomonocytic Leukaemia (JMML)

7. Known intolerance to any of the chemotherapeutic drugs in the protocol.

8. Fanconi anaemia

9. Major organ failure precluding administration of planned chemotherapy.

10. Positive pregnancy test

11. Lactating female or female of childbearing potential not using adequate contraception
Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology
Ghent, Belgium
Status: Not yet recruiting
Contact: Barbara de Moerloose, MD, PhD -
Department of Pediatrics, Aarhus University Hospital Skejby
Aarhus, Denmark
Status: Recruiting
Contact: Henrik Hasle, MD, PhD -
Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen
Copenhagen, Denmark
Status: Recruiting
Contact: Birgitte Lausen, MD, PhD -
Tallinn Children's Hospital, Dep. Hematology oncology
Tallinn, Estonia
Status: Not yet recruiting
Contact: Kadri Saks, MD, PhD -
Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital
Helsinki, Finland
Status: Recruiting
Contact: Kirsi Jahnukainen, MD, PhD -
Department of Pediatrics, Kuopio University Hospital
Kuopio, Finland
Status: Recruiting
Contact: Pekka Riikonen - +358 447172392 -
Department of Pediatrics, Oulu University Hospital
Oulu, Finland
Status: Recruiting
Contact: Merja Möttönen - +358 83155251 -
Department of Pediatrics, Tampere University Central Hospital
Tampere, Finland
Status: Recruiting
Contact: Mikko Arola - +358 3 31164386 -
Department of Pediatrics, Turku University Central Hospital
Turku, Finland
Status: Recruiting
Contact: Minna Koskenvuo, MD, PhD - +358 50 3624430 -
Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Status: Not yet recruiting
Contact: Shau-Yin Ha, MD, PhD -
Children´s Hospital, Landspitali University Hospital
Reykjavik, Iceland
Status: Not yet recruiting
Contact: Olafur Jonsson, MD, PhD -
Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology
Amsterdam, Netherlands
Status: Recruiting
Contact: Huib Caron, MD, PhD -
VU University Medical Center Department of Pediatric Oncology/Hematology
Amsterdam, Netherlands
Status: Recruiting
Contact: Gertjan Kaspers, MD, PhD -
Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center Groningen
Groningen, Netherlands
Status: Recruiting
Contact: Eveline de Bont, MD, PhD -
University Medical Center Nijmegen Department of Pediatric Oncology/Hematolog
Nijmegen, Netherlands
Status: Not yet recruiting
Contact: Dunja te Loo, MD, PhD -
Erasmus MC - Sophia Childrens Hospital University Medical Center Rotterdam
Rotterdam, Netherlands
Status: Not yet recruiting
Contact: Marry van den Heuvel-Eibrink, MD, PhD -
Department of Pediatrics, Haukeland University Hospital, Bergen
Bergen, Norway
Status: Recruiting
Contact: Dorota , Wojcik - +47 55 97 50 00 -
Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet
Oslo, Norway
Status: Recruiting
Contact: Bernward Zeller, MD, PhD -
Department of Pediatrics, University Hospital of North Norway, Tromsoe
Tromsoe, Norway
Status: Recruiting
Contact: Trond Flaegstad - +47 91507766 -
Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital
Trondheim, Norway
Status: Recruiting
Contact: Svein Kolmannskog - +47 815 55 850 -
Queen Silvias Childrens and Adolescents Hospital
Gothenburg, Sweden
Status: Recruiting
Contact: Jonas Abrahamsson, MD, PhD -
Dept of Pediatrics, Linköpings University Hospital
Linköping, Sweden
Status: Recruiting
Contact: Mikael Behrendtz, MD, PhD
Dept of Pediatrics, Skåne University Hospital
Lund, Sweden
Status: Recruiting
Contact: Cornelis Pronk, MD, PhD -
Astrid Lindgrens Barnsjukhus, Karolinska University Hospital
Stockholm, Sweden
Status: Recruiting
Contact: Karin Belander-Strålin, MD -
Dept of Pediatrics, Norrlands University Hospital
Umeå, Sweden
Status: Recruiting
Contact: Ulrika Norén-Nyström, MD, PhD -
Dept of Pediatrics, Akademiska barnsjukhuset
Uppsala, Sweden
Status: Recruiting
Contact: Josefine Palle, MD, PhD -
Start Date
March 2013
Completion Date
March 2023
Vastra Gotaland Region
Vastra Gotaland Region
Record processing date processed this data on July 28, 2015 page