A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

To be able to join this study, children and young people must have acute myeloid leukaemia (AML) that has either come back for a second or more time, or hasn't responded to at least two previous treatments. Their cancer cells must also have a specific marker called CD123, and there needs to be at least 5% AML cells in their bone marrow.

Participants also need to be reasonably well enough to take part, based on their daily activity levels. For those who are not old enough to agree for themselves, a parent or legal guardian must agree, and the child or young person must also be willing to take part if they are able to understand. They must not have serious heart problems, a history of certain liver problems, or a specific type of AML called Down syndrome-related AML, APL, or JMML. They also can't have had a stem cell transplant in the last 6 months if there are still signs of a complication called GvHD.

If you decide to take part in this study, the Pivekimab Sunirine drug will be given to you through a drip into a vein (this is called intravenous or IV). You'll receive the drug on its own. You will need to attend regular visits at a hospital or clinic. These visits will involve medical checks, blood tests, and careful monitoring for any side effects or changes in your health. These checks help the medical team see how the treatment is affecting you. The total time you would be involved in the study, including all treatments and follow-up, is about 28 months. This study might involve more visits and tests than your usual care.