BrigaPED

We are looking for a treatment that is more effective than chemotherapy with possible stem cell transplantation or surgical intervention for anaplastic large cell lymphoma (ALCL) or inflammatory myofibroblastic tumor (IMT) or another tumor with an aberration of the ALK gene (Anaplastic Lymphoma Kinase), which leads to increased tumor cell growth. This clinical study aims to evaluate the efficacy of a new experimental drug, brigatinib. Brigatinib is an ALK inhibitor, which means it specifically targets the ALK gene and is not chemotherapy. The study consists of two parts: phase 1 and phase 2. In phase 1 of the study, we will determine the safest dose of brigatinib for children. We will start by administering a dose of brigatinib equivalent to that which has been shown to be safe and effective in adult patients, but adjusted for the body weight of children. If this dose is well tolerated by the children, the dose will be increased in another group of patients up to a dose equivalent to the highest dose well tolerated by adults. Patients who start in this part and tolerate brigatinib well will receive treatment for a period of 2 years. In phase 2 of the study, we will examine the efficacy and safety of the dose as determined in phase 1 of the study in a larger group of children and young adults with ALCL or IMT with an ALK aberration. Duration: approximately two years of treatment and approximately 3 years of follow-up. In total, your child will participate in the study for about 5 years. Number of consultations, time required, and associated constraints: the child will need to come to the hospital every week for the first 5 weeks, then there will be a visit each month until the end of the 2-year treatment period and a 3-year follow-up.

Is this study suitable for my child’s condition?

Study Information

What age range of children can participate?

1 - 26 years