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

Official Title

An Open-Label, Multicentre Study of Recombinant Crisantaspase Produced in Pseudomonas Fluorescens (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. Coli-derived Asparaginases

Summary:

This is an open-label, multicentre, 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.

Trial Description

Primary Outcome:

  • Response Rate During the First Course of IM JZP-458
  • Occurrence of treatment-emergent adverse events (TEAEs)
Secondary Outcome:
  • Proportion of patients with the last 48-hour NSAA level ≥ 0.1 IU/mL during the first course of IM administration of JZP-458
  • Proportion of patients with the last 48-hour NSAA level ≥ 0.4 IU/mL during the first course of IM administration of JZP-458
  • Proportion of patients with the last 72-hour NSAA level ≥ 0.4 IU/mL during the first course of IM administration of JZP-458
  • JZP-458 Pharmacokinetics
  • Incidence of anti-drug antibody formation against JZP-458

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society