Tests two treatment combinations in children and adolescents with acute myeloid leukemia
Compares treatment options for children and teens with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: NOPHO-DBH AML 2012 Protocol: Research study for treatment of children and adolescents with acute myeloid leukemia 0-18 years
Key facts
- Where
- Aarhus N and Copenhagen Oe, DenmarkSee the 2 sites
- Phase
- Phase 3
Where in Denmark
- Region MidtjyllandAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vaestra Goetalandsregionen
- Trial code
- NCT01828489EU 2024-518254-16-00
- Record updated
- 22 November 2024
- Original description
The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols.Read full original descriptionShow less
NOPHO-DBH AML 2012 Protocol: Research study for treatment of children and adolescents with acute myeloid leukemia 0-18 years
The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols.
Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML
2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML
3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively.
Inclusion: AML as defined by the diagnostic criteria in the protocol; Age below 19 years at time of diagnosis; Written informed consent.
Exclusion: AML secondary to previous bone marrow failure syndrome; Known intolerance to any of the chemotherapeutic drugs in the protocol; Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy. They can be treated according to the protocol but will not be included in the study population. Secondary AML has a poorer response to chemotherapy but may benefit from SCT if the procedure can be tolerated; Myelodysplastic syndrome (MDS). These patients are recommended treatment according to EWOG-MDS; Major organ failure precluding administration of planned therapy; Down syndrome (DS). Patients with myeloid leukaemia of Down syndrome are recommended to be treated according to the international ML-DS protocol. Patients with AML and DS older than 5 years who often lack GATA1 mutation and do not have typical myeloid leukaemia of DS may be treated according to the protocol but will not be included in the study population; Positive pregnancy test; Lactating female or female of childbearing potential not using adequate contraception; Acute promyelocytic leukaemia (APL). These patients are recommended treatment according to the international APL Study; Juvenile Myelomonocytic Leukaemia (JMML). These patients are recommended treatment according to EWOG-MDS; Fanconi anemia.