Clinical trial · Interventional
Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Acute Myeloblastic Leukemia | Childhood Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Randomisation course 1 mitoxantrone versus DaunoXome | Drug | — | UNRESOLVED |
| Randomisation course 2 ADxE versus FLADx | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Standard arm MEC and ADxE
- description
- Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
- interventionNames
- Drug: Randomisation course 1 mitoxantrone versus DaunoXome
- Drug: Randomisation course 2 ADxE versus FLADx
- type
- EXPERIMENTAL
- label
- Experimental DxEC and standard ADxE
- description
- Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two
- interventionNames
- Drug: Randomisation course 1 mitoxantrone versus DaunoXome
- type
- EXPERIMENTAL
- label
- Standard arm MEC and experimental FLADx
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTierens 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. PMID 38603646