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Tisagenlecleucel in first-line high-risk pediatric and young adult B-ALL with MRD positivity after consolidation
2023-508081-15-00Phase 2Authorised
- Sponsor
- Novartis
- Start
- Mar 2024
- Modality
- CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
- Countries
- 11
01
Overview
Phase 2, open-label, single-arm trial of tisagenlecleucel in B cell acute lymphoblastic leukemia (B-ALL), sponsored by Novartis. Primary endpoints: 4-year overall survival rate and 5-year disease-free survival rate without censoring for new anticancer therapy. Planned start Mar 2024; status: authorised.
02
Drugs
tisagenlecleucel
03
Conditions
B cell acute lymphoblastic leukemia (B-ALL)
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