Overview

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

Status:
Active, not recruiting

Trial end date:
2022-07-01

Target enrollment:

Participant gender:

Summary

This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

Jazz Pharmaceuticals

Collaborator:

Children's Oncology Group (COG)

Treatments:

Asparaginase