Who can enter
- Children with ALK+ anaplastic large-cell lymphoma (ALCL), in case of recurrence or progression, or in remission after a recurrence
- Children 6 months of age and older
In this study, we look at the efficacy and safety of nivolumab in children with a relapse or refractory ALCL (cohort 1) or children in whom the disease is no longer apparent (in complete remission) after a relapse (cohort 2).
Nivolumab is a drug that activates the body's own immune system so that it can attack cancer cells. In adult patients, nivolumab has already been investigated for diseases such as bladder cancer and lung cancer. It was found that in some adults the tumor disappears. Nivolumab is being tested in many types of cancer in adults and children, including Hodgkin's lymphoma, where it has been shown to work well in children.
In children with relapsed or refractory ALCL, the disease has come back (relapse), or has not responded (well) to previous treatment (refractory). In this study, we want to investigate if nivolumab works in these children.
Children with early recurrence or refractory ALCL who are in remission after treatment normally receive a stem cell transplant. This is a heavy procedure. In this study, we want to investigate if we can replace the stem cell transplant with treatment with nivolumab.
This is an open-label study. This means that all children who take part in the study will be treated with nivolumab. The treatment lasts a maximum of two years.