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An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
Overall Recruitment Status: Active, currently enrolling
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
Region Sponsors
California - Northern
Jazz Pharmaceuticals, Inc.
Acronym KP IRB No.
AALL1931 1520953
Study Type Phase
Clinical Trial Phase III
Study Population Description
Pediatric and Adult Individuals with a diagnosis of Acute Lymphoblastic Leukemia and Lymphoblastic Leukemia
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
Detailed Description
Gender Age Limit
Male & Female
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
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

Keywords and/or Specific Medical Conditions
  • AALL1931
  • Lymphatic Diseases
  • Antineoplastic Agents
  • Lymphoproliferative Disorders
  • Asparaginase
  • Neoplasms
  • Immune System Diseases
  • Neoplasms by Histologic Type
  • Immunoproliferative Disorders
  • Oncology (Pediatrics)
  • JZP458-201
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia
  • Oncology (Adult)
  • Leukemia, Lymphoid
KP Clinical Facility
  • Oakland Medical Center
  • Roseville Medical Center
  • Santa Clara Medical Center-Homestead
Clinical Area
  • Oncology (Adult)
  • Oncology (Pediatrics)

Principal Investigator:
Aarati V Rao, MD
Contact Information:
- KPNC Pediatrics
-Roseville Medical Center

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