Treatment Study Using Blinatumomab for Infants Under 1 Year With KMT2A-rearranged Acute or Mixed Phenotype Leukemia

What this Trial Is About

This research aims to improve outcomes for infants under one year old diagnosed with acute lymphoblastic leukemia ALL or mixed phenotype acute leukemia MPAL that have a specific genetic change called KMT2A-rearrangement. The study focuses on a difficult-to-treat group of infants and evaluates a treatment protocol involving the drug blinatumomab. It is an international phase 3 treatment protocol led by the Princess Maxima Center for Pediatric Oncology. All eligible infants whose parents or guardians provide consent will receive one cycle of blinatumomab after initial induction therapy, alongside standard treatment. Medium risk infants who respond well to this first cycle might receive a second cycle of blinatumomab replacing one chemotherapy course. If the response is not sufficient, the infants will continue with the standard treatment. High risk infants may proceed to allogeneic stem cell transplantation if their minimal residual disease MRD levels are low enough after the first cycle. MRD is used to measure how well the treatment is working. Participants will be closely monitored with assessments of minimal residual disease and other health indicators up to eight years. The primary outcome measured is event-free survival over five years. Secondary outcomes include overall survival, treatment responses by risk group, relapse types, and adverse events. The study lasts until 2030, and all treatments and follow-ups are conducted under medical supervision to evaluate the effect of blinatumomab in this infant population.

Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia