ClinicaliQ Trial Snapshot
- Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients — Active Not Recruiting • Phase II • NCT03876769.
- Tisagenlecleucel CAR-T cell therapy for high-risk B-cell leukaemia patients with minimal residual disease after initial treatment.
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What This Trial Is Studying
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…