Who can enter
- Children with confirmed diagnosis of high-risk first relapse of acute lymphoblastic leukemia (ALL)
- Age: 1 to <18 years
Goal
There is an urgent need to improve the efficacy (removal of cancer cells) of reinduction therapy and reduce treatment side effects. Therefore, the purpose of this study is to evaluate whether inotuzumab ozogamicin is more effective in removing cancer cells after one treatment cycle than ALLR3, the standard multi-agent chemotherapy regimen.
Background
Children with ALL are currently treated with different treatment protocols. All children start with what is known as induction treatment. Treatment with ALLR3 chemotherapy is considered the standard first-line treatment for ALL by many physicians and study groups.
However, in high-risk patients ALLR3 has not been as effective in removing cancer cells with fewer side effects as it has been in other risk groups. Modern treatment approaches for ALL focus on pre-transplant removal of cancer cells, especially for patients with high-risk disease characteristics. Inotuzumab ozogamicin is expected to improve response to treatment, with fewer side effects after one treatment cycle.
Bone marrow, blood and cerebrospinal fluid samples will be collected several times during treatment to determine response rates.
The study is being conducted in 60 or more research sites in about 19 countries, mainly in Europe. In the Netherlands, the study is conducted at the Prinses Máxima Center.