Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
NCT ID: NCT01828489
Last Updated: 2017-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2013-03-31
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Standard arm MEC and ADxE
Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
Randomisation course 1 mitoxantrone versus DaunoXome
In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
Randomisation course 2 ADxE versus FLADx
The second course is randomised to either ADxE (standard arm) or FLADx
Experimental DxEC and standard ADxE
Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two
Randomisation course 1 mitoxantrone versus DaunoXome
In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
Standard arm MEC and experimental FLADx
Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two
Randomisation course 2 ADxE versus FLADx
The second course is randomised to either ADxE (standard arm) or FLADx
Experimental DxEC and experimental FLADx
Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two
Randomisation course 1 mitoxantrone versus DaunoXome
In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
Randomisation course 2 ADxE versus FLADx
The second course is randomised to either ADxE (standard arm) or FLADx
Interventions
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Randomisation course 1 mitoxantrone versus DaunoXome
In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
Randomisation course 2 ADxE versus FLADx
The second course is randomised to either ADxE (standard arm) or FLADx
Eligibility Criteria
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Inclusion Criteria
2. Age \< 19 years at time of diagnosis
3. Written informed consent
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Jonas Abrahamsson, MD, PhD
Role: STUDY_CHAIR
Children's Cancer Centre, Queen Silvias Childrens and Adolescents Hospital 416 85 Gothenburg, Sweden
Barbara de Moerloose, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology, 3K12D, De Pintelaan 185 - 9000 Gent, Belgium
Ha Shau-Yin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong, Pokfulam, Hong Kong
Henrik Hasle, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Aarhus University Hospital Skejby 8200 Aarhus N, Denmark
Kirsi Jahnukainen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital, PL 281, 00029 Helsinki, Finland
Olafur G Jonsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children´s Hospital, Landspitali University Hospital, Hringbraut, 101 Reykjavik, Iceland
Gertjan Kaspers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, VU University Medical Center Amsterdam De Boelelaan 1117, NL-1081 HV Amsterdam, The Netherlands
Birgitte Lausen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Denmark
Josefine Palle, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Woman´s and Children´s Health, Uppsala University, Uppsala, Sweden
Kadri Saks, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tallinn Children's Hospital, Dep. Hematology oncology, Tervise 28, Tallinn 13419, Estonia.
Bernward Zeller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet, Mailbox 4950 Nydalen, N-0424 Oslo, Norway
Locations
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HUDERF, L'Hôpital des Enfants Hématologie / Oncologie
Brussels, , Belgium
UZ Brussel, Pediatrische Hemato-Oncologie F930
Brussels, , Belgium
UCL, Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology
Ghent, , Belgium
UZ Leuven, Kinder Hemato-Oncologie
Leuven, , Belgium
CHR Citadelle
Liège, , Belgium
CHC Espérance
Montegnée, , Belgium
Department of Pediatrics, Aarhus University Hospital Skejby
Aarhus, , Denmark
Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen
Copenhagen, , Denmark
Tallinn Children's Hospital, Dep. Hematology oncology
Tallinn, , Estonia
Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital
Helsinki, , Finland
Department of Pediatrics, Kuopio University Hospital
Kuopio, , Finland
Department of Pediatrics, Oulu University Hospital
Oulu, , Finland
Department of Pediatrics, Tampere University Central Hospital
Tampere, , Finland
Department of Pediatrics, Turku University Central Hospital
Turku, , Finland
Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong
Hong Kong, , Hong Kong
Children´s Hospital, Landspitali University Hospital
Reykjavik, , Iceland
VU University Medical Center Department of Pediatric Oncology/Hematology
Amsterdam, , Netherlands
Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology
Amsterdam, , Netherlands
Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center Groningen
Groningen, , Netherlands
University Medical Center Nijmegen Department of Pediatric Oncology/Hematolog
Nijmegen, , Netherlands
Erasmus MC - Sophia Childrens Hospital University Medical Center Rotterdam
Rotterdam, , Netherlands
Department of Pediatrics, Haukeland University Hospital, Bergen
Bergen, , Norway
Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet
Oslo, , Norway
Department of Pediatrics, University Hospital of North Norway, Tromsoe
Tromsø, , Norway
Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital
Trondheim, , Norway
Queen Silvias Childrens and Adolescents Hospital
Gothenburg, , Sweden
Dept of Pediatrics, Linköpings University Hospital
Linköping, , Sweden
Dept of Pediatrics, Skåne University Hospital
Lund, , Sweden
Astrid Lindgrens Barnsjukhus, Karolinska University Hospital
Stockholm, , Sweden
Dept of Pediatrics, Norrlands University Hospital
Umeå, , Sweden
Dept of Pediatrics, Akademiska barnsjukhuset
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Mikael Behrendtz, MD, PhD
Role: primary
References
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Tierens A, Arad-Cohen N, Cheuk D, De Moerloose B, Fernandez Navarro JM, Hasle H, Jahnukainen K, Juul-Dam KL, Kaspers G, Kovalova Z, Lausen B, Noren-Nystrom U, Palle J, Pasauliene R, Jan Pronk C, Saks K, Zeller B, Abrahamsson J. Mitoxantrone Versus Liposomal Daunorubicin in Induction of Pediatric AML With Risk Stratification Based on Flow Cytometry Measurement of Residual Disease. J Clin Oncol. 2024 Jun 20;42(18):2174-2185. doi: 10.1200/JCO.23.01841. Epub 2024 Apr 11.
Other Identifiers
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2012-002934-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NOPHO-DBH-AML2012
Identifier Type: -
Identifier Source: org_study_id
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