drugset / Trial / NCT04943952
JZP458 - Recombinant Erwinia Asparaginase for Treatment of ALL / LBL Patients With Hypersensitivity to E. Coli-derived Asparaginase
Summary
This study is an Expanded Access Protocol (EAP) of JZP458 in participants with ALL/LBL who are hypersensitive to an E.coli-derived asparaginase (allergic reaction or silent inactivation) and unable to access alternative licensed treatment, to receive JZP458 treatment prior to potential Food and Drug Administration (FDA) approval and commercial availability.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asparaginase Erwinia chrysanthemi | Protein / enzyme biologic | — | Intramuscular |