This study looks at acute promyelocytic leukemia (APL) in children and adolescents. APL is a blood cancer that starts in very early white blood cells. The purpose of the study is to learn how well treatment works and how safe it is for young people with newly diagnosed APL. The treatment uses arsenic trioxide together with tretinoin, and in some patients with higher-risk disease it also includes gemtuzumab ozogamicin. Other medicines listed in the study materials include cytarabine, methotrexate, and methylprednisolone, which may be used as part of the treatment plan or support care. Some medicines are given by mouth and others are given into a vein or into the fluid around the spine, depending on the treatment step.
The study follows a treatment course made up of several phases. At first, treatment is given to bring the leukemia under control. After that, more treatment is given over time to help keep the disease from returning. Some children may receive only the main drug combination, while others may receive an added medicine based on the type of APL and the level of risk. During the study, doctors watch for side effects and monitor how the disease responds to treatment.
The study is designed for newly diagnosed APL in children and adolescents and compares treatment approaches for different risk groups. The study also examines whether the treatment causes any serious problems and how long children stay in the hospital during therapy.
Czechia 
France 
Italy 
Sweden 
The Netherlands 
