Who can enter
- Children and adolescents with B-precursor acute lymphoblastic leukemia (ALL) or B-cell non-Hodgkin lymphoma (NHL) who did not or insufficiently respond to standard treatment (refractory), or in whom the disease has returned (relapsed).
- Age ≤21 years (ALL) or <18 years (NHL)
The goal of this study is to determine whether CAR T cells (in this case KTE-X19 CAR T cells made by the company Kite Pharma), given to children after three days of chemotherapy, are safe and effective in the treatment of children with relapsed or refractory ALL or NHL.
The experimental treatment in this study is called KTE-X19.
KTE-X19, made by the company Kite Pharma, is a so-called CAR T-cell therapy (immunotherapy). T cells (a type of white blood cells) are filtered from the patient’s blood and are modified in the laboratory so that they can detect and destroy cancer cells. The modified cells are called ‘chimeric antigen receptor’ (CAR) T cells.
The CAR T cells are returned to the patient via infusion. They can now recognize the protein CD19 that is present on the surface of leukemia and lymphoma cells, and also on normal B cells.
The goal of the treatment with CAR T cells is to achieve remission. There is too little experience to tell whether treatment with CAR T cells alone is sufficient in the long run to cure the leukemia or lymphoma. Therefore, the need for further treatment (e.g. stem cell transplantation) will be examined.