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Clinical trial

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

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Last updated:1st Nov 2019
Identifier: NCT04145531

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.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 135 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter 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
Estimated Study Start Date: November 2019
Estimated Primary Completion Date: November 2020
Estimated Study Completion Date: March 2021

- Experimental:

Category Value
Date last updated at source 2019-10-30
Study type(s) Interventional
Expected enrolment 135
Study start date 2019-11-01
Estimated primary completion date 2020-11-01

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