Who can enter
- Children with 'very high risk' CD22-positive B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in whom the disease has returned (relapsed) very quickly
- Age: 1-18 years
Goal
The safe dose of InO has been determined earlier in this study. The safety and efficacy of InO at this dose has been studied further in a larger group of children with relapsed/refractory ALL. In this part of the study the efficacy of InO will be examined in children with ‘very high risk’ BCP-ALL.
Background
Some children with B-cell precursor ALL or another B-cell malignancy have recurrent disease or do not respond to treatment. Only a minority of them can still be cured with intensive chemotherapy and a stem cell transplantation. This study with InO was designed to improve that.
The drug InO targets leukemia and lymphoma cells. It binds to a protein on the surface of the leukemia or lymphoma cell (called CD22), and then delivers a chemotherapeutic drug (calicheamicin) in the cell. CD22 only occurs on leukemia and lymphoma cells, and on some mature blood cells.
In Europe InO has already been approved (‘registered’) for the treatment of adults with relapsed/refractory ALL. In North America and Japan, it has also been registered as a drug for the treatment of children with relapsed/refractory BCP-ALL, based on the results of the first phase of this study.
In the first phase of this study the safe dose of InO was determined, and approximately 40 children were treated with the same InO dose. More than 80% of these children achieved complete remission. In 94% of the children who achieved remission no minimal residual disease was present. The latter is important because the results of a stem cell transplantation, which is usually required after achieving complete remission, are much better when there is no or very little residual disease detectable.
In the second phase of this study approximately 30 children were treated with a combination of InO and other chemotherapy. This did not result in a better response.
In the current part of the study the efficacy of InO will be examined in a specific group of patients.
This study is being performed by a collaboration of universities and pediatric hospitals throughout Europe. This European group is called ITCC.