©2024 Stanford Medicine
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Not Recruiting
Trial ID: NCT01643408
Purpose
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.
Official Title
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.
Eligibility
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:
-
Intervention(s):
drug: asparaginase Erwinia chrysanthemi
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krysta Schlis
650-723-5535