Who can enter
- Children and teenagers with newly diagnosed acute lymphoblastic leukemia (ALL).
- Age: 1 to 18 years (in the Netherlands).
The goal of the clinical studies that belong to ALLToghether1 is to improve survival and reduce side effects in children and young adults with ALL. Additionally, we want to learn more about the disease, so we may further improve the treatment in the future.
Children with ALL are currently treated according to the ALLTogether1 protocol. In five or six phases they receive different types of chemotherapy. All children start with the so-called induction treatment. The subsequent treatment depends on the genetic characteristics of the leukemic cells, and on how the disease responds to the induction treatment. Bone marrow, blood and spinal fluid samples will be drawn a number of times during the treatment, in order to determine the response.
With the current treatment approximately 90% of children with ALL can be cured. For further improvement of the standard treatment we want to combine the ALLTogether1 protocol with clinical studies.
First of all, we will record the disease characteristics and treatment data of all children being treated according to ALLTogether1 in a database. These data will help us gain more insight into the efficacy and side effects of the drugs.
Furthermore, we want to store body material (bone marrow, blood and spinal fluid) in the Princess Máxima Center. This concerns residual material that is left over after determining the diagnosis or the response to treatment. This material will be used in clinical studies belonging to the ALLTogether1 protocol. The goal is to better understand how and why leukemic cells arise, and how side effects occur. This way we may be able to improve the treatment and prevent side effects in the future.
One part of the study is aimed at the relation between the amount of the drug PEG-asparaginase in the blood, its efficacy, and possible side effects that patients experience. In another part of the study we want to develop better tests to detect leukemia in the brain, and to determine which patients need less or more treatment to the brain.
This clinical study has been set up by the ALLTogether Consortium (a collaboration of 14 different European countries) and is being performed in several hospitals. In the Netherlands, this study is performed in the Princess Máxima Center.