Who can enter
- Children and teenagers with classic Hodgkin lymphoma in whom the disease has returned (relapse) or responded insufficiently to the treatment (refractory)
- Age: 5-17 years (in the Netherlands)
Goal
The goal of this study is to determine how effective the drug nivolumab is in combination with the drug brentuximab vedotin in children and teenagers with classic Hodgkin lymphoma. We also want to see which side effects can occur due to the treatment.
Depending on the response to this treatment (nivolumab and brentuximab vedotin), this is followed by treatment with brentuximab vedotin and the drug bendamustin. We want to find out whether these treatments increase the chance of complete response (complete reaction of the disease to the drugs) or whether it will take longer for the disease to possibly return or deteriorate.
Background
In some children and teenagers with Hodgkin lymphoma the disease responds insufficiently to the treatment (refractory), or the disease returns (relapse). This is probably because the disease is less sensitive to the drugs that were given.
The natural defense system of our body (the immune system) can recognize and destroy cancer cells. Cancer cells often try to prevent this by putting the brake on the immune system. The drug nivolumab is an antibody (immunotherapy ) that releases that brake, so the immune system can again attack the cancer cells.
Nivolumab is registered (approved) for the treatment of multiple types of cancer in adults, among which classical Hodgkin lymphoma. It has not yet been registered for use in children. Since 2016, more than 80 children have been treated in other trials with nivolumab, either alone or in combination with the drug ipilimumab. This was well tolerated. The side effects seen thus far are consistent with those seen in adults.
This study is the first to explore the combination of the drugs nivolumab and brentuximab vedotin in children. In case of a suboptimal response, this is followed by treatment with brentuximab vedotin and bendamustin. These drugs have not yet been registered for use in children either. However, much is already known about their use in children with Hodgkin lymphoma. In this study nivolumab, brentuximab vedotin, and bendamustin are all regarded as experimental medication. This study is performed in multiple centers in Europe and the United States.