Who can enter
- Infants with newly diagnosed B-cell precursor acute lymphoblastic leukemia (ALL) who are treated according to the Interfant-06 protocol, belong to the medium or high risk group, and who have M1 or M2 bone marrow at the end of induction therapy.
- Age: 0-1 year at diagnosis.
Goal
The goal of this study is to establish whether the drug blinatumomab can be safely added to standard treatment in infants with medium or high risk ALL, who were diagnosed with this disease in their first year of life. We will also determine whether blinatumomab is effective in these infants.Background
Approximately four percent of children with ALL are infants (0-1 year old). Most of them have MLL-gene abnormalities, which means they have a poorer prognosis than older children with ALL. New treatments are needed to improve their outcomes.
Blinatumomab is an antibody and is therefore not called chemotherapy but immunotherapy. One part of this antibody binds to the protein CD19 on the surface of leukemic cells, and the other part to the body’s own immune cells (T cells). Blinatumomab thus enables the T cells to recognize and destroy the leukemic cells.
In previous studies blinatumomab demonstrated anti-tumor activity in both adults and children with ALL. This drug has now been approved for the treatment of adults and children (≥ 1 year) with precursor B-cell ALL who relapsed or were refractory to other treatments.
In this study we will evaluate whether blinatumomab can be safely added to the standard treatment of infants with medium- or high-risk ALL, and whether this is more effective than the standard treatment.