Who can enter
- Children with CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) or other CD22-positive B-cell malignancies, who did not respond or insufficiently responded to standard treatment (refractory), or in whom the disease has returned (relapsed).
- Age: 1-18 years.
The goal of this study is to first determine a safe dose of InO in children with relapsed of refractory B-cell precursor ALL. In the second phase we will use that dose to evaluate the safety and efficacy of InO in a larger group of children with relapsed/refractory ALL, or with other CD22-positive B-cell malignancies.
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 and North America InO has already been approved (‘registered’) for the treatment of adults with relapsed/refractory ALL, but it has not yet been registered as a drug for the treatment of children.
Phase 1 of this study was recently completed. In this phase 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.
This study is being performed by a collaboration of universities and pediatric hospitals throughout Europe. This European group is called ITCC.