Status:
UNKNOWN
Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Pediatric Acute Myeloblastic Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
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 st...
Eligibility Criteria
Inclusion
- AML as defined by the WHO diagnostic criteria
- Age \< 19 years at time of diagnosis
- Written informed consent
Exclusion
- Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
- AML secondary to previous bone marrow failure syndrome.
- Down syndrome (DS)
- Acute promyelocytic leukaemia (APL)
- Myelodysplastic syndrome (MDS)
- Juvenile Myelomonocytic Leukaemia (JMML)
- Known intolerance to any of the chemotherapeutic drugs in the protocol.
- Fanconi anaemia
- Major organ failure precluding administration of planned chemotherapy.
- Positive pregnancy test
- Lactating female or female of childbearing potential not using adequate contraception
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01828489
Start Date
March 1 2013
End Date
March 1 2023
Last Update
January 10 2017
Active Locations (32)
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1
HUDERF, L'Hôpital des Enfants Hématologie / Oncologie
Brussels, Belgium, 1020
2
UZ Brussel, Pediatrische Hemato-Oncologie F930
Brussels, Belgium, 1090
3
UCL, Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
4
Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology
Ghent, Belgium, 9000