This clinical trial is focused on studying a treatment for children with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL). The study is specifically for cases where the disease has returned or has not responded to previous treatments. The treatment being tested is called Inotuzumab Ozogamicin, which is used alone or in combination with chemotherapy. The goal of the study is to find the best dose of Inotuzumab Ozogamicin for children and to see how effective it is in treating this type of leukemia.

Inotuzumab Ozogamicin is a medication that targets a specific protein found on the surface of cancer cells, known as CD22. By targeting this protein, the drug aims to destroy the cancer cells while sparing healthy cells. The study will also explore the safety and side effects of the treatment, as well as how well it works in combination with other chemotherapy drugs. The trial is divided into different parts, each focusing on different aspects of the treatment, such as its effectiveness and safety.

Participants in the study will receive the treatment over several cycles, and their response to the treatment will be closely monitored. The study aims to provide valuable information on how Inotuzumab Ozogamicin can be used to treat children with relapsed or refractory ALL, potentially leading to better treatment options in the future. The study is expected to continue until 2027, allowing researchers to gather comprehensive data on the treatment’s effectiveness and safety.