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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jazz Pharmaceuticals
• Treatments: Asparaginase

Criteria

Inclusion Criteria:

• Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,

• Ages >/= 1 and
• Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma

• Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol

• Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol

• Direct bilirubin less than or equal to Grade 2

• Amylase and lipase within normal limits (per institutional standards)

• Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.

Exclusion Criteria:

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