Summary
This is a single arm, open-label, multi-center, phase II study to determine the efficacy
and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who
received first-line treatment and are EOC MRD positive. The study will have the following
sequential phases: screening, pre-treatment, treatment & follow-up, and survival. After
tisagenlecleucel infusion, patient will have assessments performed more frequently in the
first month and then at Day 29, then every 3 months for the first year, every 6 months
for the second year, then yearly until the end of the study. Efficacy and safety will be
assessed at study visits and as clinically indicated throughout the study. The study is
expected to end in approximately 8 years after first patient first treatment (FPFT). A
post-study long term follow-up safety will continue under a separate protocol per health
authority guidelines.