Who can enter
- Children and young adults with B-cell or T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) who did not or insufficiently respond to standard treatment (refractory), or in whom the disease has returned (relapsed).
- Age: 1-30 years old.
The goal of this study is to determine how safe and effective daratumumab is in the treatment of relapsed ALL and LL in children, and to find out what the possible side effects might be in children.
In order to improve the treatment of children and young adults with ALL or LL, doctors want to add the agent daratumumab to the standard treatment with chemotherapy.
Daratumumab is a monoclonal antibody: a protein that can recognize another, unique protein (in this case CD38) and bind to it (immunotherapy). CD38 is present on the surface of tumor cells in ALL or LL. Binding of daratumumab to CD38 alerts the immune system, which can then recognize and destroy the tumor cell.
Daratumumab has already been used in adults with multiple myeloma (also a type of blood cancer), but it is new for people with ALL or LL. Daratumumab is not expected to be sufficiently active as a single agent. Therefore, in this study we will combine this agent with standard chemotherapy. The study is conducted in multiple European and American centers.