Skip Navigation Links
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.
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
 
Purpose
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
  • Antineoplastic Agents
  • Lymphoproliferative Disorders
  • Asparaginase
  • Neoplasms
  • Immune System Diseases
  • Neoplasms by Histologic Type
  • Immunoproliferative Disorders
  • Oncology (Pediatrics)
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Lymphoid
  • Oncology (Adult)
  • Lymphatic Diseases
 
KP Clinical Facility
  • Oakland Medical Center
  • Roseville Medical Center
  • Santa Clara Medical Center-Homestead
 
Clinical Area
  • Oncology (Adult)
  • Oncology (Pediatrics)


Principal Investigator:
Laura Campbell, MD
Contact Information:
- KPNC Pediatrics
-Susan.X.Leu@kp.org
-Roseville Medical Center


smilelady1
Do you want to receive
Email Alerts?

Sign Up Here!





Regional Research Sites: