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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma

Intervention / Treatment
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* Drug: asparaginase Erwinia chrysanthemi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: -

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label Erwinaze<br> | Drug: asparaginase Erwinia chrysanthemi<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two Day Nadir Serum Asparaginase Activity (NSAA) Level | To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 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. | 48 hours post-dose 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours | To report the proportion of participants achieving 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 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. | 48 hours post-dose 5 | 
| Three Day NSAA Level | To report the mean 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | 72 hours post-dose 6 | 
| Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours | To report the proportion of participants achieving 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | 72 hours post-dose 6 | 
| Nadir Serum Asparaginase Activity Over Time | To describe the NSAA over time in participants 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). | 4 weeks to 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Erwinaze, asparaginase, Eusa Pharma, Pharmacokinetic study, NSAA