Plain-English translation of NCT05327894 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether a medication called , added to standard chemotherapy, can help babies under one year old with a rare type of leukemia that has a specific genetic change (KMT2A-rearranged). Babies in this study will receive at least one round of the medication on top of their regular cancer treatment. The goal is to see if this medication can help more babies survive and stay cancer-free longer.
Infant leukemia with this genetic change is very aggressive and hard to treat with chemotherapy alone. This trial exists to see if adding this medication can improve survival and give babies a better chance of long-term recovery.
You likely qualify if…
You likely don't qualify if…
Your baby will receive standard chemotherapy as the foundation of treatment, with at least one cycle of the new medication added during or after initial treatment. Doctors will use blood tests to measure how well the treatment is working (called minimal residual disease testing) to decide if your baby needs additional cycles of the medication or other options like stem cell transplant. The exact schedule depends on how your baby's leukemia responds and whether they are classified as medium or high risk based on factors like age and initial blood counts.
AI-generated summary from trial data · Jul 16, 2026 · Not medical advice
Argentina
Australia