NCT01643408

A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

Phase II, An Open Label, Single Arm, Multi-Center Pharmacokinetic Study of Intravenous Erwinaze (Asparaginase Erwinia Chrysanthemi)Following Allergy to Native E. Coli Asparaginase (Elspar or Kidrolase), Pegaspargase (Oncaspar) or Calaspargase Pegol (EZN-2285) in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

Summary

This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.

Conditions

• Acute Lymphoblastic Leukemia
• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	asparaginase Erwinia chrysanthemi

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-08-01
• Completion: 2013-12-01
• First posted: 2012-07-18
• Last updated: 2021-06-23
• Results posted: 2021-06-23

Locations

22 sites across 2 countries: United States, Canada