ALLTogether1 - Treatment Study Protocol for Children and Young Adults 0-45 Years with Newly Diagnosed Acute Lymphoblastic Leukaemia

What this Trial Is About

Researchers are evaluating a new treatment system called ALLTogether1 for infants, children, and young adults aged 0 to 45 years diagnosed with acute lymphoblastic leukaemia ALL. This European study combines previous successful treatments from multiple groups to improve survival and quality of life. It addresses the challenge that some patients are over-treated while others relapse, aiming to find better risk-based treatment approaches and reduce side effects and relapse rates. The study uses a master protocol with established standard therapies and includes several randomized sub-studies to test different treatment modifications. These include reducing or omitting certain chemotherapy drugs, adding targeted therapies like Inotuzumab ozogamicin, Imatinib, 6-tioguanine, or Blinatumomab, and tailoring treatment for specific genetic subgroups. The study design allows adding or stopping sub-studies to find less toxic but effective therapies for various risk groups. Participants will undergo diagnosis confirmation and risk stratification, followed by assigned treatments according to their risk category and randomization group. Assessments include measuring event-free survival, disease relapse, molecular responses, and adverse effects over at least five years. Additional sub-studies collect biological samples and evaluate cognitive function, drug activity, and treatment toxicities. Safety and long-term outcomes are closely monitored throughout the study period.

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia