Who can enter
- Children and adolescents with mature B-cell non-Hodgkin lymphoma (B-NHL) who did not or insufficiently respond to standard treatment (refractory), or in whom the disease has returned (relapsed).
- Age: 1-25 years old.
Goal
The goal of this study is to determine how safe and effective the new tisagenlecleucel treatment is for children and adolescents with refractory or relapsed mature B-NHL.
Background
In this study researchers test an innovative method for the treatment of relapsed or refractory B-NHL in children and adolescents.
Tisagenlecleucel, made by the company Novartis, is a so-called CAR T-therapy (immunotherapy). T cells (a certain 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 T cells are returned to the patient via infusion. They can now recognize the protein CD19 that is present on the surface of lymphoma cells, and kill these cells.
Tisagenlecleucel has been approved (‘registered’) for the treatment of certain types of acute leukemia in children, and for certain types of B-cell lymphoma in adults. But it has not yet been registered for the treatment of children and adolescents with relapsed or refractory B-NHL. Clinical studies are required in order to allow prescription of this agent for these patients as well.