Summary

Location
at Oakland, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Mignon Loh

Description

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.

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

Keywords

Acute Lymphoblastic Leukemia Lymphoblastic Leukemia ALL LBL Asparaginase Leukemia Childhood acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid IM JZP-458 IV JZP-458 JZP-458

Eligibility

You can join if…

  1. Pediatric and adult patients with a diagnosis of ALL or LBL.
  2. Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation.
  3. Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment plan.
  4. Patients must have, in the opinion of the Investigator, fully recovered from their prior allergic reaction to E. coli-derived asparaginase.

You CAN'T join if...

  1. Have previously received asparaginase Erwinia chrysanthemi or JZP-458.
  2. Have relapsed ALL or LBL.
  3. Are concurrently receiving another investigational agent and/or treated with an investigational device at the same time as JZP-458 (within 48 hours) during Course 1 of JZP-458.
  4. Have a history of ≥ Grade 3 pancreatitis.
  5. Prior history of asparaginase-associated ≥ Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events.

Locations

  • Benioff Children's Hospital Oakland accepting new patients
    Oakland California 94609 United States
  • University of California San Francisco Benioff Children's Hospital - Mission Bay accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jazz Pharmaceuticals
ID
NCT04145531
Phase
Phase 2/3
Study Type
Interventional
Last Updated