Pediatric Acute Myeloblastic Leukemia Clinical Trial
— AML2012Official title:
NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
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).
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | March 2023 |
| Est. primary completion date | March 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | HUDERF, L'Hôpital des Enfants Hématologie / Oncologie | Brussel | |
| Belgium | UCL, Cliniques Universitaires Saint-Luc | Brussel | |
| Belgium | UZ Brussel, Pediatrische Hemato-Oncologie F930 | Brussel | |
| 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 | |
| Denmark | Department of Pediatrics, Aarhus University Hospital Skejby | Aarhus | |
| Denmark | Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen | Copenhagen | |
| Estonia | Tallinn Children's Hospital, Dep. Hematology oncology | Tallinn | |
| Finland | 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 | |
| Hong Kong | Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong | Hong Kong | |
| Iceland | Children´s Hospital, Landspitali University Hospital | Reykjavik | |
| Netherlands | Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology | Amsterdam | |
| Netherlands | VU University Medical Center Department of Pediatric Oncology/Hematology | 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 | |
| Norway | 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 | Tromsoe | |
| Norway | Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital | Trondheim | |
| Sweden | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Vastra Gotaland Region |
Belgium, Denmark, Estonia, Finland, Hong Kong, Iceland, Netherlands, Norway, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Event-free survival | Event-free survival at five years | 5 years | Yes |
| Secondary | Acute toxicity | Hematological and other organ toxicity after each course | six months | Yes |
| Secondary | Long-term toxicity | Long-term toxicity in particular cardiac toxicity | 10 years | Yes |
| Secondary | Overall survival | Overall survival at five years | Five years | Yes |