Niiza

Researchers are evaluating a treatment protocol using blinatumomab for infants under 1 year old diagnosed with acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia who have a specific genetic change called KMT2A-rearrangement. This study aims to improve outcomes for these very young patients with this challenging disease. The trial is a Phase 3 international collaboration focusing on this rare population. All enrolled infants will receive one cycle of blinatumomab after their initial induction therapy, alongside standard treatment. Medium risk patients who respond well to the first cycle may receive a second cycle replacing one chemotherapy course after consolidation therapy. Those who do not respond well will follow the current standard treatment. High risk patients who become minimal residual disease (MRD) negative after the first blinatumomab cycle may be eligible for allogeneic stem cell transplantation. MRD levels guide treatment decisions throughout the protocol. Participants will be closely monitored with assessments including MRD testing to measure response to treatment. The main outcome measured is event-free survival over 5 years. Parents or legal guardians will provide informed consent prior to enrollment. The study involves continuous intravenous infusion of blinatumomab over four weeks per cycle and follows infants through treatment and follow-up to evaluate long-term outcomes and safety.