AALL1721: A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy

The purpose of this study is to find out if the study drug, tisagenlecleucel, is safe and has benefits for people who have high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL) and have a tiny number of leukemia cells still present in their bone marrow (MRD positive) at the end of consolidation (EOC) therapy. Tisagenlecleucel is a product made up of the patient's own T cells that have been changed to be able to identify and kill leukemia cells. Patients will receive chemotherapy followed by tisagenlecleucel and then be monitored to see how well the treatment worked.

Are you Eligible? (Inclusion Criteria)

• Subjects must be at least 1 year and up to 25 years at the time of screening
• Subject must have CD19 expressing B-ALL
• Subjects must be newly diagnosed NCI high risk B-ALL who are receiving initial treatment and still have a small amount of leukemia
• Subjects must also meet all eligibility criteria as outlined in the study protocol