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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002934-35 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard arm MEC and ADxE | Active Comparator | Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two |
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| Experimental DxEC and standard ADxE | Experimental | Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two |
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| Standard arm MEC and experimental FLADx | Experimental | Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two |
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| Experimental DxEC and experimental FLADx | Experimental | Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Randomisation course 1 mitoxantrone versus DaunoXome | Drug | In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | On day 22 after the first induction and after second induction |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Event-free survival at five years | 5 years |
| Acute toxicity | Hematological and other organ toxicity after each course |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonas Abrahamsson, MD, PhD | Contact | +46 707695159 | jonas.abrahamsson@vgregion.se | |
| Anna Schröder-Håkansson | Contact | anna.schroder-hakansson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Jonas Abrahamsson, MD, PhD | Children's Cancer Centre, Queen Silvias Childrens and Adolescents Hospital 416 85 Gothenburg, Sweden | Study Chair |
| Barbara de Moerloose, MD, PhD | Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology, 3K12D, De Pintelaan 185 - 9000 Gent, Belgium |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUDERF, L'Hôpital des Enfants Hématologie / Oncologie | Recruiting | Brussels | 1020 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38603646 | Derived | 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. |
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| Randomisation course 2 ADxE versus FLADx | Drug | The second course is randomised to either ADxE (standard arm) or FLADx |
|
| six months |
| Long-term toxicity | Long-term toxicity in particular cardiac toxicity | 10 years |
| Overall survival | Overall survival at five years | Five years |
| Principal Investigator |
| Ha Shau-Yin, MD, PhD | Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong, Pokfulam, Hong Kong | Principal Investigator |
| Henrik Hasle, MD, PhD | Department of Pediatrics, Aarhus University Hospital Skejby 8200 Aarhus N, Denmark | Principal Investigator |
| Kirsi Jahnukainen, MD, PhD | Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital, PL 281, 00029 Helsinki, Finland | Principal Investigator |
| Olafur G Jonsson, MD, PhD | Children´s Hospital, Landspitali University Hospital, Hringbraut, 101 Reykjavik, Iceland | Principal Investigator |
| Gertjan Kaspers, MD, PhD | Department of Pediatrics, VU University Medical Center Amsterdam De Boelelaan 1117, NL-1081 HV Amsterdam, The Netherlands | Principal Investigator |
| Birgitte Lausen, MD, PhD | Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Denmark | Principal Investigator |
| Josefine Palle, MD, PhD | Dept of Woman´s and Children´s Health, Uppsala University, Uppsala, Sweden | Principal Investigator |
| Kadri Saks, MD, PhD | Tallinn Children's Hospital, Dep. Hematology oncology, Tervise 28, Tallinn 13419, Estonia. | Principal Investigator |
| Bernward Zeller, MD, PhD | Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet, Mailbox 4950 Nydalen, N-0424 Oslo, Norway | Principal Investigator |
| UZ Brussel, Pediatrische Hemato-Oncologie F930 | Recruiting | Brussels | 1090 | Belgium |
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| UCL, Cliniques Universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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| Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology | Recruiting | Ghent | 9000 | Belgium |
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| UZ Leuven, Kinder Hemato-Oncologie | Recruiting | Leuven | 3000 | Belgium |
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| CHR Citadelle | Recruiting | Liège | Belgium |
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| CHC Espérance | Recruiting | Montegnée | Belgium |
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| Department of Pediatrics, Aarhus University Hospital Skejby | Recruiting | Aarhus | 8200 | Denmark |
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| Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen | Recruiting | Copenhagen | Denmark |
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| Tallinn Children's Hospital, Dep. Hematology oncology | Not yet recruiting | Tallinn | 13419 | Estonia |
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| Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital | Recruiting | Helsinki | 00029 | Finland |
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| Department of Pediatrics, Kuopio University Hospital | Recruiting | Kuopio | 70211 | Finland |
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| Department of Pediatrics, Oulu University Hospital | Recruiting | Oulu | 90029 | Finland |
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| Department of Pediatrics, Tampere University Central Hospital | Recruiting | Tampere | 33521 | Finland |
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| Department of Pediatrics, Turku University Central Hospital | Recruiting | Turku | 20520 | Finland |
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| Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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| Children´s Hospital, Landspitali University Hospital | Not yet recruiting | Reykjavik | Iceland |
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| VU University Medical Center Department of Pediatric Oncology/Hematology | Recruiting | Amsterdam | 1007 | Netherlands |
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| Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology | Recruiting | Amsterdam | 1100 DD | Netherlands |
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| Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center Groningen | Recruiting | Groningen | 9700 RB | Netherlands |
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| University Medical Center Nijmegen Department of Pediatric Oncology/Hematolog | Recruiting | Nijmegen | 6500 HB | Netherlands |
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| Erasmus MC - Sophia Childrens Hospital University Medical Center Rotterdam | Recruiting | Rotterdam | 3000 CB | Netherlands |
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| Department of Pediatrics, Haukeland University Hospital, Bergen | Recruiting | Bergen | 5021 | Norway |
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| Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet | Recruiting | Oslo | N-0424 | Norway |
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| Department of Pediatrics, University Hospital of North Norway, Tromsoe | Recruiting | Tromsø | N-9038 | Norway |
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| Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital | Recruiting | Trondheim | N-7006 | Norway |
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| Queen Silvias Childrens and Adolescents Hospital | Recruiting | Gothenburg | 41685 | Sweden |
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| Dept of Pediatrics, Linköpings University Hospital | Recruiting | Linköping | 58185 | Sweden |
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| Dept of Pediatrics, Skåne University Hospital | Recruiting | Lund | 22241 | Sweden |
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| Astrid Lindgrens Barnsjukhus, Karolinska University Hospital | Recruiting | Stockholm | 17176 | Sweden |
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| Dept of Pediatrics, Norrlands University Hospital | Recruiting | Umeå | 90185 | Sweden |
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| Dept of Pediatrics, Akademiska barnsjukhuset | Recruiting | Uppsala | 751 85 | Sweden |
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