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

Why are we doing this research?

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.

AALL1931 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

Who can participate?

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Have previously received asparaginase Erwinia chrysanthemi or JZP-458.
  • Have relapsed ALL or LBL.
  • 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.
  • Have a history of ≥ Grade 3 pancreatitis.
  • Prior history of asparaginase-associated ≥ Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events.

Ages

  • No age limitations

Conditions

  • Leukemia ALL New Diagnosis
  • Leukemia ALL Relapse
  • Adult - Leukemia ALL New Diagnosis
  • Adult - Leukemia ALL Relapse
  • Lymphoma Non Hodgkin Relapse
  • Lymphoma Non Hodgkin New Diagnosis
  • Adult - Lymphoma Non Hodgkin Relapse
  • Adult - Lymphoma Non Hodgkin New Diagnosis

Contact

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org