Pediatric Acute Myeloblastic Leukemia
Conditions
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).
Interventions
DRUGRandomisation course 1 mitoxantrone versus DaunoXome
In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
DRUGRandomisation course 2 ADxE versus FLADx
The second course is randomised to either ADxE (standard arm) or FLADx
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal residual disease | On day 22 after the first induction and after second induction | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival | 5 years | Event-free survival at five years |
| Acute toxicity | six months | Hematological and other organ toxicity after each course |
| Long-term toxicity | 10 years | Long-term toxicity in particular cardiac toxicity |
| Overall survival | Five years | Overall survival at five years |
Countries
Belgium, Denmark, Estonia, Finland, Hong Kong, Iceland, Netherlands, Norway, Sweden
Contacts
Primary ContactJonas Abrahamsson, MD, PhD
Backup ContactAnna Schröder-Håkansson
Outcome results
None listed