Who can enter
- Children with newly diagnosed Acute Promyelocytic Leukemia (APL)
- Age: younger than 18 years old
The goal of this study is to evaluate the safety and efficacy of the use of a combination of the medicines ATRA and ATO in the treatment of children with APL.
For children in the High Risk group we will also add the medicine GO to the beginning of their treatment.
APL is a type of Acute Myeloid Leukemia where there is a shortness of normal blood cells, and an abnormal accumulation of immature white blood cells called promyelocytes.
APL can be very well treated with a combination of a certain kind of chemotherapy and a medicine called ATRA. Approximately 80% of the children with APL is cured with this treatment. However, this treatment gives many side effects.
Many adult patients have already been treated successfully with a combination of the medicines ATRA (a medicine derived from vitamin A) and ATO (arsenic trioxide). This treatment approach without chemo, with only ATRA and ATO, has been studied in only a few children.
Children with a low level of white blood cells in their blood at diagnosis (Standard Risk Group, SR-APL) will be treated with a combination of ATRA and ATO.
In children with a high level of white blood cells in their blood at diagnosis (High-Risk Group, HR-APL) treatment with ATRA and ATO alone is not sufficient. For these children the medicine GO (gemtuzumab ozogamicin) will be added in the beginning of the treatment.
In this study we will evaluate if this treatment approach is also successful in the treatment of children and adolescents, and will give less side effects.