Who can enter
- Children and young adults with AML receiving an allogeneic stem cell transplant with cord blood
- Age: 0-30 years (starting with patients aged 16 years or older)
Goal
The goal of this study is to enable the patient's immune system to clear up any residual disease that may be present after the stem cell transplant. By giving the patient a vaccine with specific donor cells, we hope to strengthen the patient's defenses against any remaining tumor cells. This may lower the chances of the disease returning. We will also look at the safety of the vaccine and what side effects may result from this vaccination.
Background
We are investigating the effect of specific dendritic cell vaccinations. Dendritic cells are part of the immune system, as are T cells. Dendritic cells "tell" those T cells what to take action against. The vaccines consist of dendritic cells grown from a portion (20%) of the stem cells from the donor cord blood with which the patient is also transplanted. In this way we ensure that the vaccinations for the new immune system, created from the donor's cells, are the right match for the patient.
During culture, the dendritic cells (to be used for vaccinations) are loaded with specific characteristics of the AML. When this vaccine is then administered to the patient, we believe that this vaccine provides T cells with the instruction to be able to recognize and clear AML cells. In this way, the immune system is then trained to detect and destroy AML cells.
The patient has a form of AML with a specific "genetic characteristic". We call this WT1-positive AML. This vaccine is made so specific that it should enable the patient's T cells to recognize, attack and destroy WT1-positive AML cells.
Vaccination against AML is not part of standard treatment. It is only given when consent is given. The vaccinations are additional subcutaneous and intravenous injections.
Following the start of the study, the patients will be closely monitored to see how they respond to the vaccinations. This will be done in the first year after the stem cell transplant. We call this follow-up. During this year, an additional 5 ml of blood will be taken each time during blood draws that the patient will have anyway. So this is not an extra puncture. The additional blood is taken to measure the effect of the vaccination in the blood. The development of the number of any remaining WT1-positive AML cells is also examined.