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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

This is a study of tisagenlecleucel of for high risk B-cell acute lymphoblastic leukemia in children and young adults. The goal is to find out how safe it is and how well it works. Tisagenlecleucel is a kind of medicine made up of cells (a "cell therapy"). It is made by taking immune cells called T cells (a type of white blood cell) and changing them in a lab in way that makes them able to find and destroy cancer cells.
Suzanne Treadway at streadway@pennstatehealth.psu.edu or 717-531-3097
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This study is NOT accepting healthy volunteers
NCT03876769
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Inclusion Criteria:
Ages 1-25 inclusive
Diagnosis of B-cell Acute Lymphoblastic Leukemia (B-ALL)
Positive test result for CD19
MRD Positive test result at the end of consolidation treatment
Exclusion Criteria:
Treatment with any prior gene or engineered T cell therapy
Philadelphia chromosome positive (Ph+) ALL
M3 marrow at the completion of first-line induction therapy
Cancer
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Location
Hershey, PA