Clinical trial NCT01828489: Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
Official title: NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pediatric Acute Myeloblastic Leukemia
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2013-04-10
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Minimal residual disease
timeFrame: On day 22 after the first induction and after second induction
Secondary outcomes:
measure: Event-free survival
timeFrame: 5 years
measure: Acute toxicity
timeFrame: six months
measure: Long-term toxicity
timeFrame: 10 years
measure: Overall survival
timeFrame: Five years
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: HUDERF, L'Hôpital des Enfants Hématologie / Oncologie
city: Brussel
country: Belgium
facility: UZ Brussel, Pediatrische Hemato-Oncologie F930
city: Brussel
country: Belgium
facility: UCL, Cliniques Universitaires Saint-Luc
city: Ghent
country: Belgium
facility: Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology
city: Leuven
country: Belgium
facility: UZ Leuven, Kinder Hemato-Oncologie
city: Liège
country: Belgium
facility: CHR Citadelle
city: Montegnée
country: Belgium
facility: CHC Espérance
city: Aarhus
country: Denmark
facility: Department of Pediatrics, Aarhus University Hospital Skejby
city: Copenhagen
country: Denmark
facility: Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen
city: Tallinn
country: Estonia
facility: Tallinn Children's Hospital, Dep. Hematology oncology
city: Helsinki
country: Finland
facility: Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital
city: Kuopio
country: Finland
facility: Department of Pediatrics, Kuopio University Hospital
city: Oulu
country: Finland
facility: Department of Pediatrics, Oulu University Hospital
city: Tampere
country: Finland
facility: Department of Pediatrics, Tampere University Central Hospital
city: Turku
country: Finland
facility: Department of Pediatrics, Turku University Central Hospital
city: Hong Kong
country: Hong Kong
facility: Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong
city: Reykjavik
country: Iceland
facility: Children´s Hospital, Landspitali University Hospital
city: Amsterdam
country: Netherlands
facility: VU University Medical Center Department of Pediatric Oncology/Hematology
city: Amsterdam
country: Netherlands
facility: Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology
city: Groningen
country: Netherlands
facility: Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center Groningen
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen Department of Pediatric Oncology/Hematolog
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Sophia Childrens Hospital University Medical Center Rotterdam
city: Bergen
country: Norway
facility: Department of Pediatrics, Haukeland University Hospital, Bergen
city: Oslo
country: Norway
facility: Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet
city: Tromsoe
country: Norway
facility: Department of Pediatrics, University Hospital of North Norway, Tromsoe
city: Trondheim
country: Norway
facility: Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital
city: Gothenburg
country: Sweden
facility: Queen Silvias Childrens and Adolescents Hospital
city: Linköping
country: Sweden
facility: Dept of Pediatrics, Linköpings University Hospital
city: Lund
country: Sweden
facility: Dept of Pediatrics, Skåne University Hospital
city: Stockholm
country: Sweden
facility: Astrid Lindgrens Barnsjukhus, Karolinska University Hospital
city: Umeå
country: Sweden
facility: Dept of Pediatrics, Norrlands University Hospital
city: Uppsala
country: Sweden
facility: Dept of Pediatrics, Akademiska barnsjukhuset
Study officials:
affiliation: Children's Cancer Centre, Queen Silvias Childrens and Adolescents Hospital 416 85 Gothenburg, Sweden
name: Jonas Abrahamsson, MD, PhD
role: STUDY_CHAIR
affiliation: Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology, 3K12D, De Pintelaan 185 - 9000 Gent, Belgium
name: Barbara de Moerloose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong, Pokfulam, Hong Kong
name: Ha Shau-Yin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Aarhus University Hospital Skejby 8200 Aarhus N, Denmark
name: Henrik Hasle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital, PL 281, 00029 Helsinki, Finland
name: Kirsi Jahnukainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children´s Hospital, Landspitali University Hospital, Hringbraut, 101 Reykjavik, Iceland
name: Olafur G Jonsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, VU University Medical Center Amsterdam De Boelelaan 1117, NL-1081 HV Amsterdam, The Netherlands
name: Gertjan Kaspers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Denmark
name: Birgitte Lausen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Woman´s and Children´s Health, Uppsala University, Uppsala, Sweden
name: Josefine Palle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tallinn Children's Hospital, Dep. Hematology oncology, Tervise 28, Tallinn 13419, Estonia.
name: Kadri Saks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet, Mailbox 4950 Nydalen, N-0424 Oslo, Norway
name: Bernward Zeller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: