Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
A phase II trial of tisagenlecleucel in first line high risk (HR) pediatric and young adult patients with B cell acute ymphoblastic leukemia (B ALL) who are minimal residual isease (MRD) positive at the end of consolidation (EOC) therapy
NCT Number:
NCT03876769
Phase:
II
Protocol Type:
Treatment
Age Group:
Children
Disease Sites:
Leukemia, other
Study Objectives:
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, efficacy will be assessed 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. Safety will be assessed 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 for lentiviral vector safety will continue under a separate protocol per health authority guidelines.
Study Documents
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