CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 229 enrolled
Drug / intervention
IM JZP-458 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04145531
NCT04145531Phase 3Completed
CompareCT.gov

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

Jazz Pharmaceuticals·interventional·Posted Oct 30, 2019·Updated Nov 18, 2023

In Brief

A Phase 3 clinical trial evaluating IM JZP-458 and IV JZP-458 for Acute Lymphoblastic Leukemia and Lymphoblastic Leukemia. Completed, enrolled 229 participants across 74 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia, Lymphoblastic Leukemia
CountriesCanada, United States
CollaboratorsChildren's Oncology Group

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 30, 2019
Enrollment StartDec 27, 2019
Primary CompletionJul 13, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.7 years ago

Interventions

IM JZP-458drug

IM JZP-458 will be administered in Part A, Cohorts 1 \& 2

IV JZP-458drug

IV JZP-458 will be administered in Part B