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Clinical Trial Summary

This is a single arm, multi-center, phase II study to evaluate the efficacy and safety of tisagenlecleucel in Chinese pediatric and young adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)


Clinical Trial Description

The study will have the following sequential phases for all subjects: - Screening - Pre-Treatment (Cell Product Preparation and Lymphodepleting Chemotherapy) - Treatment and Follow-up Tisagenlecleucel infusion should occur within 16 weeks of informed consent. The total duration of the study is 5 years. After tisagenlecluecel infusion, efficacy will be assessed monthly for the first 6 months, then quarterly up to 2 years and semi-annually afterwards up to 5 years, or until the subject relapses. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04156659
Study type Interventional
Source Novartis
Contact
Status Withdrawn
Phase Phase 2
Start date November 30, 2021
Completion date November 30, 2027

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