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JZP458 - Recombinant Erwinia Asparaginase for Treatment of ALL / LBL Patients With Hypersensitivity to E. Coli-derived Asparaginase

NCT04943952 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2021-08-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Asparaginase Erwinia Chrysanthemi (recombinant)

Participants will receive JZP458 via intramuscular injection.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943952 on ClinicalTrials.gov