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



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


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


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.


  • Benioff Children's Hospital Oakland
    Oakland California 94609 United States
  • University of California San Francisco Benioff Children's Hospital - Mission Bay
    San Francisco California 94158 United States
  • Kaiser Permanente - Oakland Medical Center
    Oakland California 94611 United States

Lead Scientist at UCSF

  • Mignon Loh
    Professor, Office of the CEO, Chancellor/EVC/FAS. Authored (or co-authored) 255 research publications


in progress, not accepting new patients
Start Date
Completion Date
Jazz Pharmaceuticals
Phase 2/3 research study
Study Type
Last Updated