Summary

Location
at UC Davis UCSF
Dates
study started
estimated completion

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 Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • University of California San Francisco Benioff Children's Hospital - Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Kaiser Permanente- Los Angeles Medical Center accepting new patients
    Los Angeles California 90027 United States
  • Children's Hospital of Orange County Main Campus - Orange accepting new patients
    Orange California 92868 United States

Details

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