A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
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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 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.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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To determine the proportion of patients with 2 day nadir serum asparaginase activity (NSAA) levels (48 hour levels taken after the 5th dose) that are > or = to 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose
Secondary Outcome Measures :
3 day NSAA level [ Time Frame: 4 weeks ]
To determine the proportion of patients with 3 day NSAA level (72 hour levels taken after the 6th dose)that are > or = to 01 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose
Asparaginase related toxicities [ Time Frame: Up to 30 weeks ]
To describe the frequency of asparaginase related toxicities within the first 3 or 4 weeks of treatment associated with intravenous Erwinaze treatment in patients with ALL/Lymphoblastic Lymphoma who have developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol.
NSAA over time [ Time Frame: 4 - 30 weeks ]
To describe the NSAA over time in patients with ALL/Lymphoblastic Lymphoma who have/had developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol and are receiving intravenous Erwinaze 3 times per week for a prolonged duration (4-30 weeks).
Frequency of asparaginase related toxicities in patients with longer duration of Erwinaze use. [ Time Frame: Up to 30 weeks ]
To describe the frequency of asparaginase related toxicities associated with intravenous Erwinaze treatment in patients with ALL/Lymphoblastic Lymphoma and who have developed hypersensitivity to Native E. coli asparaginase, Pegaspargase or Calaspargase pegol with longer duration of Erwinaze use (4 - 30 weeks).
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Layout table for eligibility information
Ages Eligible for Study:
1 Year to 30 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
Ages >/= 1 and </= to 30 years at the time of initial diagnosis
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 byt he patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.