NOPHO-DBH AML 2012 Protocol: Research study for treatment of children and adolescents with acute myeloid leukemia 0-18 years

Prior treatment

• AML secondary to previous bone marrow failure syndrome.
• Known intolerance to any of the chemotherapeutic drugs in the protocol.

Other illness

• 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

Age

• 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.

Other

• 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

• AML as defined by the diagnostic criteria in the protocol
• Age below 19 years at time of diagnosis
• Written informed consent